1062 - Applied Antitrust Law

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Appeal: 12-1172

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CASE NO. 12-1172 ________________________ IN THE UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT _____________________________________ THE NORTH CAROLINA STATE BOARD OF DENTAL EXAMINERS, Petitioner v. FEDERAL TRADE COMMISSION, Respondent ________________________ ON PETITION FOR REVIEW OF AN ORDER OF THE FEDERAL TRADE COMMISSION ________________________ JOINT APPENDIX, VOLUME I9 ________________________ Noel L. Allen M. Jackson Nichols Catherine E. Lee Nathan E. Standley Brenner A. Allen, of counsel ALLEN, PINNIX & NICHOLS, P.A. Post Office Drawer 1270 Raleigh, North Carolina 27602 Telephone: 919-755-0505 Facsimile: 919-829-8098 Email: [email protected] [email protected] [email protected] [email protected] [email protected] Counsel for Petitioner

Imad Dean Abyad John F. Daly FEDERAL TRADE COMMISSION 600 Pennsylvania Avenue, N.W. Washington, D.C. 20580 Telephone: 202-326-2375 Facsimile: 202-326-2477 Email: [email protected] [email protected] Counsel for Respondent

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CASE NO. 12-1172 INDEX TO DOCUMENTS IN APPENDIX VOLUME I Pleadings Description of Item/Date Relevant Docket Entries FTC’s Administrative Complaint (6/17/10) Response to Complaint (7/6/10) Complaint Counsel’s Motion for Partial Summary Decision (11/2/10) Respondent’s Motion to Dismiss (11/3/10) Respondent’s Motion to Change Hearing Location (1/14/11) Respondent’s Motion to Disqualify the Commission (1/14/11) Order Denying Respondent’s Motion to Change Hearing Location (1/25/11) Opinion of the Commission [non-public version] and Order Denying Respondent’s Motion to Dismiss, Granting Complaint Counsel’s Motion for Partial Summary Decision, Denying Respondent’s Motion to Disqualify the Commission, and Granting Respondent’s Motion for Leave to File Limited Surreply Brief (2/3/11) Commission Opinion Denying Respondent’s Motion to Disqualify the Commission (2/16/11) Order Denying Respondent’s Motion to Dismiss at the Close of Evidence Offered in Support of the Complaint (3/30/11) Complaint Counsel’s Post-Trial Proposed Final Stipulations of Law, Fact, and Authenticity [excerpts] (4/25/11) Initial Decision and Order (7/14/11) Respondent’s Notice of Appeal (7/28/11) 2   

Record Appendix Entry No. Page No. N/A 1 R.1 12 R.6 19 R.22 43 R.25 R.59

49 53

R.61

60

R.83

72

R.98

76 94

R.114

96

R.129

104

R.142

109

R.165 R.167

116 250

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Description of Item/Date Oral Argument Before the Commission [excerpt] (10/28/11) Opinion and Final Order of the Commission (12/7/11) Respondent’s Application for Stay of Order Pending Review by U.S. Court of Appeals (1/13/12) Order on Respondent’s Application for Stay of Order R.182 Pending Review by U.S. Court of Appeals (2/10/12) Petition for Review w/o exhibits A-F (2/10/12)

Record Appendix Entry No. Page No. R.176 253 R.177 R.180

265 311

R.183

332

R.184

339

VOLUME II Excerpts from Hearing Transcripts Name Hearing Transcript Giniger, Dr. Martin

Hearing Transcript Giniger, Dr. Martin Hearing Transcript Gibson, John William Nelson, George

Osborn, Joyce

Nature of Testimony Direct Direct Direct Direct Direct Cross Direct Direct Direct Direct Direct Direct Direct Cross Cross Direct Direct Cross

Date 2/17/2011 2/17/2011 2/17/2011 2/17/2011 2/17/2011 2/17/2011 2/18/2011 2/18/2011 2/23/2011 2/23/2011 2/23/2011 2/23/2011 2/23/2011 2/23/2011 2/23/2011 2/23/2011 2/23/2011 2/23/2011 2/23/2011 2/23/2011 2/23/2011

3   

Cited Page Nos. 111-121 128-132 149-150 169-172 180-183 461-466 613-615 622-633 733-736 740-743 769 774-778 785-789 834 850-851 653-656 668-675 716-719

Appendix Page No. 343 344 355 360 362 366 370 371 377 405 408 436 440 444 445 450 455 456 420 424 432

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Name Valentine, James Patrick

Filed: 07/06/2012

Nature of Testimony Direct Direct Direct Cross Cross

Hearing Transcript Hughes, Margie

Direct Direct Direct Direct Direct Direct

Kwoka, Dr. John

Wyant, Brian David Hearing Transcript Kwoka, Dr. John

Cross Cross Cross

Hearing Transcript Owens, Ronald K., DDS

Direct Direct Direct Direct Direct Direct Cross Direct Direct Direct Direct Direct Direct Cross Cross Cross Cross Cross Cross

Wester, Millard W., III

   

Date 2/23/2011 2/23/2011 2/23/2011 2/23/2011 2/23/2011 2/24/2011 2/24/2011 2/24/2011 2/24/2011 2/24/2011 2/24/2011 2/24/2011 2/25/2011 2/25/2011 2/25/2011 2/25/2011 2/28/2011 2/28/2011 2/28/2011 2/28/2011 2/28/2011 2/28/2011 2/28/2011 2/28/2011 2/28/2011 2/28/2011 2/28/2011 2/28/2011 2/28/2011 2/28/2011 2/28/2011 2/28/2011 2/28/2011 2/28/2011 2/28/2011 2/28/2011

 

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Cited Page Nos. 523-533 561-570 575 597-599 606-607 934-936 940-948 981-984 994-997 1005-1009 870-885 1114-1115 1136-1137 1219 1436-1438 1440 1445 1449-1454 1457-1459 1464 1474-1475 1278 1280-1281 1285-1286 1288 1290-1291 1300-1302 1311-1315 1321 1323-1324 1337-1338 1352-1353 1400-1408

Appendix Page No. 378 389 399 400 403 458 475 478 487 491 495 459 500 501 503 505 506 539 542 543 544 550 553 554 507 508 510 512 513 515 518 523 524 526 528 530

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Name

Nature of Testimony

Hearing Transcript Owens, Ronald K., DDS

Cross Cross Cross Cross

Hearing Transcript Baumer, David Lee

Direct Direct Cross Cross Cross Cross Cross Cross Cross Cross

Hearing Transcript Runsick, Brian Keith Hearing Transcript White, Bobby

 

Direct Direct Direct Direct Direct Direct Direct Direct Direct Cross Cross

Date 3/1/2011 3/1/2011 3/1/2011 3/1/2011 3/1/2011 3/2/2011 3/2/2011

3/3/2011 3/3/2011 3/3/2011 3/8/2011 3/8/2011 3/8/2011 3/8/2011 3/8/2011 3/8/2011 3/8/2011 3/8/2011 3/8/2011 3/8/2011

 

5   

Cited Page Nos. 1576-1579 1589-1590 1618-1621 1662-1664 1763 1781 1845-1850 1855-1856 1859-1862 1884-1885 1896-1898 1900-1903 1910-1915 1926-1935 2108-2109 2111-2116 2194 2197-2198 2202-2203 2208-2209 2219-2220 2226-2227 2232-2234 2255 2317-2319

Appendix Page No. 556 557 561 563 567 570 571 572 573 579 581 585 587 590 594 600 610 611 613 619 620 621 623 625 627 269 631 634 635

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Name Hearing Transcript Haywood, Van Benjamin

Hearing Transcript Hardesty, Willis Stanton, Jr.

Haywood, Van Benjamin Hearing Transcript Haywood, Van Benjamin

Nature of Testimony Direct Direct Direct Direct Direct Direct Direct Direct Direct Direct Direct Direct Direct Direct Cross Cross Cross Cross Cross Cross Cross Cross Cross

Date 3/9/2011 3/9/2011 3/9/2011 3/9/2011 3/9/2011 3/9/2011 3/9/2011 3/9/2011 3/9/2011 3/9/2011 3/9/2011 3/10/2011 3/10/2011 3/10/2011 3/10/2011 3/10/2011 3/10/2011 3/10/2011 3/10/2011 3/10/2011 3/10/2011 3/10/2011 3/10/2011 3/10/2011 3/16/2011 3/16/2011

6   

Cited Page Nos. 2403 2449 2458-2459 2461-2462 2464 2472-2474 2530 2545 2567-2568 2570-2572 2762-2766 2771-2772 2774-2776 2780-2785 2804-2805 2818-2823 2829 2856-2858 2864-2866 2695-2696 2713-2714 2728-2729 2915-2917

Appendix Page No. 638 639 640 641 643 645 646 649 650 651 653 656 663 668 670 673 679 681 687 688 691 657 659 661 694 695

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VOLUME III Excerpts from Designated Deposition Transcripts Name

Date

Allen, Stanley L., Jr., DDS

9/3/2010

Bakewell, Carolin

10/13/2010

Baumer, David L., Ph.D, J.D. Brown, Benjamin W., DDS

1/21/2011

Burnham, Joseph S., Jr., DDS

10/8/2010

Efird, Zannie Poplin Feingold, Clifford O., DDS

9/1/2010 10/5/2010

Cited Page Nos. 18 26-27 33-35 38 79-81 87-88 181-182 214-215 318 28-34

Nature of Testimony Direct Direct Direct Direct Direct Direct Direct Direct Direct Direct

Appendix Page No. 699 700 702 705 707 710 712 714 716 718

8 15-17 26-27 40-41 43-44 77-79 101-102 104 222 224-225 70 72-73 114-115 146-147 151-153 171-174 41 10-11 49 64-66

Direct Direct Direct Direct Direct Direct Direct Direct Cross Cross Direct Direct Direct Direct Direct Direct Direct Direct Direct Direct

726 727 730 732 734 736 739 741 742 743 746 747 749 751 753 756 761 763 765 766

9/2/2010

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Name

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Date

Friddle, Teresa W.

10/14/2010

Friddle, Teresa W. (Investigational Hearing) Goode, Casie S. (Investigational Hearing) Hall, Neplus S.

7/7/2009

Hardesty, Willis Stanton, Jr., DDS

10/29/2010

W. Stan Hardesty, Jr., DDS (Investigational Hearing) Hasson, Michael L., DDS

7/23/2009

Holland, Charles Wayne, DDS

7/8/2009

Cited Page Nos. 22-23 59 62-63 6-15 39 96 24-26

Nature of Testimony Direct Direct Direct Direct Direct Direct Direct

Appendix Page No. 770 772 773 776 786 787 789

4-5 16 34 38 53-55 60-62 67 87 98 145 30-31

Direct Direct Direct Direct Direct Direct Direct Direct Direct Direct Direct

793 795 796 798 799 802 805 806 807 808 810

60 62-63 85-87 32-33 35-38 49-51 84-85 138-139 145-146 154-156 248

Direct Direct Direct Direct Direct Direct Direct Direct Direct Direct Cross

813 814 816 820 822 826 829 831 833 835 838

9/1/2010

11/16/2010

9/17/2010

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Name

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Date

Kurdys, Sean

10/7/2010

Morgan, Brad C., DDS

10/15/2010

Owens, Ronald K., DDS Oyster, Gary D., DDS Parker, Alec M., DDS Runsick, Brian Keith Tilley, Larry F., DDS

11/8/2010

Cited Page Nos. 17 37-38 53 57 81-82 30 80-83 127-128 146 258-259 287-288 169-170

Nature of Testimony Direct Direct Direct Direct Direct Direct Direct Direct Direct Direct Cross Direct

Appendix Page No. 840 841 843 844 845 848 849 853 855 856 858 861

14-15 32 8-10

Direct Direct Direct

864 866 868

60-61 113-115 139-140 16 21-22 50-52 7-10

Direct Direct Direct Direct Direct Direct Direct

672 875 878 881 882 884 888

9/24/2010 9/23/2010 11/4/2010 11/12/2010

Wester, Millard W., III, DDS

9/3/2010

White, Bobby D.

11/9/2010

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Complaint Counsel’s Exhibits Exhibit Number CX25

Description

Letter to Dr. Benjamin Brown from Terry Friddle re: Welcome Back to the NC Dental Board dated 6/26/03

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Appendix Page No. 892

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Exhibit Number CX28

CX32 CX33 CX35

CX36

CX38 CX42 CX43 CX44

CX45

CX50

CX54

CX56 CX58

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Filed: 07/06/2012

Description

Letter to Dr. Millard "Buddy" Wester from Bobby White & Terry Friddle: re: Welcome to the NC Dental Board dated 6/25/08 E-mail to Terry Friddle from [email protected] re: Great White Case #03-184 dated 7/15/2004 Fax to Dr. Benjamin Brown from Terry Friddle re: Richard Yeager DDS Complaint dated 9/28/2003 Fax to NCBoard from Kelly Kreeb, DDS re: Edie’s Salon Panache Offering TW Services dated 10/15/2004 Fax to Dr. Stanley Allen from Terry Friddle: re: Caryn Massari, DDS re: Edie’s Salon Complaint dated 10/7/2004 Letter to Serenity Day Spa from Terry Friddle: re: taking dental impressions dated 1/11/06 Collection of letters sent on same day to BleachBright locations from Board dated 1/19/09 Fax to Carolyn Bakewell from Jerry Butler DDS re: BleachBright dated 10/27/2008 E-mail to Friddle, Dempsey, Smith et al. from Burnham: re: Star Bright Whitening Systems at Cutting Crib dated 5/15/06 Fax to Dr. Joseph Burnham from Terry Friddle re: Star Bright Whitening Systems, Inc. dated 5/12/2006 Letter to Terry Friddle from Pamela Weaver: re: Cease and Desist Letter to Nicole's Hair dated 3/27/07 Fax to Dr. Stan Hardesty from Terry Friddle re: Dr. Reese Complaint Form – Signature Spas dated 9/11/2006 Minutes from NC Dental Board Meeting: Morrisville, NC dated 2/9/2007 Letter to Tom Jones Drug from Casie Goode dated 2/18/09

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Cited Page Nos. 1

Appendix Page No.

1-8

894

1-5

902

1-2

907

1-18

909

1-5

927

1-40

932

1-13

972

1-6

985

1-7

991

1-3

998

1-6

1001

1-8

1007

1-2

1015

893

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Exhibit Number CX59 CX65

CX66 CX67 CX68 CX69 CX70 CX74 CX77 CX79 CX80 CX92

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Description

Letter to Port City Tanning from Casie Goode dated 10/7/08 Letter to Patrice Barragan (Sunsational Tan) from Carolin Bakewell re: White Science dated 12/27/2007 Letter to Algis Augustine from Carolin Bakewell re: White Science Email to Van Essen from Carolin Bakewell: re: Teeth whitening Memo dated 2/7/07 Letter to Joe Willett (BleachBright- Crabtree Valley Mall) from Casie Goode dated 2/20/08 Letter to Sherry Johnson (Body Mind and Spirit) from Terry Friddle dated 3/29/07 E-mail to Friddle from Holland re: Body, Mind & Spirit Day Spa Log #06-217 dated 3/22/2007 Letter to Dotson, Nelson and York (Celebrity Smiles) from Terry Friddle dated 11/21/07 Letter to Champagne Taste from Carolin Bakewell dated 2/8/07 Letter to Tim Williams (Movie Star Smile) from Casie Goode dated 12/18/07 E-mail to Friddle, Dempsey and White from Dr. Brown re: Case 04-090 dated 11/7/2005 E-mail from Treman to Goode re: www.shinewhite.net/retailers.php dated 3/4/2008

Cited Page Nos. 1-2

Appendix Page No.

1

1019

1

1020

1-3

1021

1-2

1024

1-2

1026

1-2

1028

1-2

1030

1-2

1032

1-2

1034

1-2

1036

1

1038

1-6

1039

1-4

1045

1-2

1049

1

1051

1017

VOLUME IV CX94 CX96 CX97 CX100

Letter to Terry Friddle from Joe Bracey: re: Sean Powers- Order to Cease and Desist dated 12/18/07 Letterto Margie Hughes (SheShe Studio Spa) from Terry Friddle dated 2/23/07 Letter from to Patrice Barragan (Sunsational Tan) from Terry Friddle dated 9/4/07 Letter to White Science from Bakewell dated 12/4/2007 11 

 

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Exhibit Number

Description

CX102

Letter to Kyle Taylor from Carolin Bakewell re: Status of Whitening Kiosks in Carolina Place Mall Closed Session Minutes from NC Dental Board Meeting in Morrisville, NC 8/10-8/11/2007 & 2/78/2008 dated 8/10/2007, see Sealed Volume VI below E-mail to Bakewell from Recker re: your letter May 9, 2007 dated 7/24/2007 Closed Session Minutes from NC Dental Board Meeting in Morrisville, NC 3/14-3/15/2008 dated 3/14/2008, see Sealed Volume VI below Letter to White Science from Carolin Bakewell re: selling teeth whitening services to non-dental professionals dated 2/13/2007 E-mail to Dr. Holland from Terry Friddle re: Log 09-047 Please Assign w/attach: Complaint Form from Dr. Stephen Smith dated 2/18/2011 Letter to Jason & Shanon Rabon (Sunsational Tan) from Terry Friddle dated 3/26/09 Letter to Fantasticians from Casie Goode dated 9/24/08 Letter to Florida White Smile from Casie Goode dated 10/7/08 Letter to Joe Willett (iBriteExpress) from Casie Goode dated 9/24/08 E-mail to Dr. Holland from Terry Friddle: re: Log 09-049 Please Assign Case dated 2/18/09 Letter to Ortho Depot from Friddle re: Unlawful Practice of Dentistry dated 10/3/2000 Letter to Barry Hughie (DOWD Central YMCA) from Terry Friddle dated 2/12/2002 Letter to Barry Hughie (DOWD Central YMCA) from Friddle re: setting a dental practice dated 12/10/2001 Letter to Serenity Total Body Care/Bleach Bright from Casie Goode dated 9/22/09

CX106

CX108 CX109

CX110

CX111

CX112 CX120 CX122 CX123 CX128 CX136 CX138 CX139

CX153

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Cited Page Nos. 1-3

Appendix Page No.

1-5

v.VI 1698

1-42

1055

1-3

v.VI 1703

1

1097

1-6

1098

1-2

1104

1-2

1106

1-2

1108

1-2

1110

1

1112

1

1113

1

1114

1

1115

1-2

1116

1052

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Exhibit Number

Description

CX155

Letter to Heather Wiecek (Buena Vista Smiles) from Casie Goode dated 12/14/09 Letter to Suave D's-BleachBright from Casie Goode dated 12/22/09 The News & Observer: State Lets Whitening Kiosks Be dated 3/19/2010 Letter to Board from Tonya Norwood (Modern Enhancement Salon) dated 2/9/2009 American Dental Association: Talking Points; Whitening at a Salon or Mall Kiosk by Unlicensed Individuals dated 1/2010 Fax to NC Dental Board from Dr. Davis re: Movie Star Smile ad in Hickory Daily Record dated 2/6/2008 Letter to Blue Ridge Mall from Carolin Bakewell dated 11/21/07 Letter to CBL & Associates Properties from Carolin Bakewell dated 11/21/07 Letter to Colonial Mayberry Mall Office from Carolin Bakewell dated 11/21/07 Minutes from NC Dental Board Meeting in Morrisville, NC 8/10-11/2007 dated 8/10/2007 Letter to Clifford Feingold from NC Dental Board: re: Welcome Letter & Training Information dated 7/8/05 Memorandum to Members of the Board from Terry Friddle: re: Closed Investigative Files dated 11/13/06 Letter to Joseph Burnham from NC Dental Board: re: Welcome Letter & Training Information dated 6/26/03 E-mail to Kurdys from Bishop re: Teeth Whitening at Southpoint Mall Investigative Memo to Owens and Bakewell from Kurdys: re: Mr. Shawn Powers (Savage Tan) dated 8/30/07

CX156 CX158 CX162 CX185

CX198

CX203 CX204 CX205 CX206 CX219

CX235

CX242

CX245 CX247

13   

Cited Page Nos. 1-2

Appendix Page No.

1-2

1120

1-2

1122

1

1124

1

1125

1-2

1126

1-2

1128

1-2

1130

1-2

1132

1-5

1134

1

1139

3

1140

1

1141

1

1142

1

1143

1118

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Exhibit Number

Description

CX249

Investigative Memo to Owens and Bakewell from Kurdys: re: Bailey's Lightening Whitening dated 8/13/08 Investigative Memo to Holland & Bakewell from Kurdys re: Inspire Skin & Body (Felicia Brown; Case 08-214) dated 2/3/2009 E-mail to White from Bakewell re: Teeth Whitening dated 11/27/2007 E-mail to White from Bakewell re: Teeth Whitening dated 3/24/2008 Fax to Frank Recker from Terry Friddle re: Celebrity Smiles Cease & Desist Letter dated 11/20/2007 Letter to Algis Augustine from Carolin Bakewell: re: Joe Willett/BleachBright dated 3/10/08 Investigative Memo to Hardesty & Bakewell from Dempsey re: Spa White/White Science (07-020) dated 11/21/2007 Letter to Cleveland Mall Office from Carolin Bakewell dated 11/21/07 Letter to General Growth Properties from Carolin Bakewell dated 11/21/07 Letter from Hendon Properties from Carolin Bakewell re: Unauthorized Tooth Whitening Kiosk dated 11/21/2007 Letter to University Mall Office from Carolin Bakewell dated 11/21/07 Letter to Westfield Eastridge Mall Office from Carolin Bakewell dated 11/21/07 E-mail to BCFamilyDentistry, CC: White & Friddle from Bakewell re: Salon Ads Submitted by Dr. Mathew dated 9/8/2008 Chart of Carolin Bakewell's Cases dated 3/11/09, see Sealed Volume VI below Letter to Inspire Skin & Body from Casie Goode dated 4/3/09

CX251

CX254 CX255 CX256

CX257 CX258

CX259 CX260 CX261

CX262 CX263 CX265

CX270 CX272

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Cited Page Nos. 1

Appendix Page No.

1-2

1145

1

1147

1-2

1148

1-3

1150

1

1153

1-2

1154

1-2

1156

1-2

1158

1-2

1160

1-2

1162

1-2

1164

1

1166

1-2

v.VI 1706 1167

1-2

1144

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Exhibit Number

Description

CX276

List of Teeth Whitening Case Files, see Sealed Volume VI below Letter to NC Dental Board from Nicole LeCann re: Bleach Bright in Crabtree Valley Mall dated 2/27/2008 Letter to Shohreh Rafie (Carmel Day Spa & Salon) dated 10/1/07 E-mail to Friddle, Bakewell & White from Hardesty re: Concern about Unlicensed Person Bleaching Teeth dated 1/20/2007 E-mail to Weinstein & Smith from Hardesty re: Concerning about Unlicensed Person Bleaching Teeth dated 1/19/2007 E-mail to Friddle and White from Hardesty: re: Case Assignment 06-198 dated 9/12/06 Investigative Memo to Stanley Allen and Denise Stafford from Terry Friddle: re: Edie's Salon Panache dated 10/7/04 E-mail to Friddle, Bakewell & White from Hardesty re: Salon Bleaching dated 1/20/2007 E-mail to Friddle, White & Bakewell from Holland re: Case Assignment 08-214 dated 12/1/2008 E-mail to Friddle from Hyman re: Lightening Whitening dated 6/17/2008 E-mail to Friddle from Owens re: Case Assignment 09-269 dated 12/10/2009 Letter to Boone Mall Management from Carolin Bakewell dated 11/21/07 Letter to Northgate Mall Office from Carolin Bakewell dated 11/21/07 Letter to Randolph Mall Management Office from Carolin Bakewell dated 11/21/07 E-mail to [email protected] from Bakewell re: Illegal Tooth Whitening Kiosks at Crabtree Valley Mall dated 11/21/2007

CX278

CX279 CX281

CX282

CX283 CX284

CX293 CX297

CX304 CX311 CX323 CX324 CX325 CX326

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Appendix Page No.

1

v.VI 1708 1169

1-2

1170

1

1172

1

1173

1

1174

2

1175

1-2

1176

1-8

1178

1

1186

1-2

1187

1-2

1189

1-2

1191

1-2

1193

1-2

1195

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Exhibit Number

Description

CX347

E-mail to Dempsey, Friddle, Smith et al. from Hardesty: re: Amazing Grace Spa (07-021) dated 1/16/08 Investigative Memo to Holland and Bakewell from Dempsey: re: Body, Mind, & Spirit Day Spa dated 8/7/07 E-mail to Dempsey, Friddle, Smith et al. from Owens re: Case 07-208 Celebraity Smiles (Southpoint) Letter to Christiane Dotson and Sherry Nelson (Celebrity Smiles) from Terry Friddle dated 11/20/07 Investigative Memo to Hardesty and Bakewell from Dempsey: re: SheShe Studio Spa dated 8/7/07 E-mail to Dempsey from Neal re: Teeth Whitening dated 2/13/2008 Investigative Memo to Feingold and Bakewell from Dempsey: re: Carmel Day Spa and Salon dated 9/24/07 E-mail to Friddle from Owens re: Whitening Spa dated 11/20/2007 Memorandum to Members of the Board from Terry Friddle: re: Closed Investigative Files dated 9/7/07, see Sealed Volume VI below E-mail to White, Burnham, Hardesty et al. from Owens re: Teeth Whitening dated 3/17/2008 Letter to Enhanced Light Technologies from Carolin Bakewell re: Illegal Teeth Whitening dated 2/13/2007 Dr. W. Stan Hardesty's Response to the FTC's Subpoena Duces Tecum dated 9/7/10 Letter to Alan Elrod from Terry Friddle dated 1/31/07 Letter to Bailey's Lightning Whitening from Terry Friddle dated 7/17/08

CX348

CX350

CX351

CX353

CX354 CX361

CX365 CX368

CX369 CX371

CX378 CX386 CX387

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Appendix Page No.

1

1198

1

1199

1-2

1200

1

1202

1

1203

1

1204

1-2

1205

1-2, 5 1

v.VI 1710 1712 1207

1

1208

3, 12 1-2

1209 1210 1211

1-2

1213

1197

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Exhibit Number

Description

CX388

Letter to Lite Brite from Terry Friddle dated 7/17/08 Letter to Triad Body Secrets from Terry Friddle dated 9/24/08 Letter to Whitening on Wheels from Terry Friddle dated 11/12/08 Letter to Cynthia Blust (The Extra Smile, Inc.) from Terry Friddle dated 12/31/08 Tooth Whitening/Bleaching: Treatment Considerations for Dentists and their Patients dated 9/2009 [excerpt] AACD: First It Was Atkins, Then It Was South Beach, Now It’s the White Smile Diet dated 6/22/2008 Symposium on Esthetic Restorative Materials: History, Safety and Effectiveness of Current Bleaching Techniques: Applications of the Nightguard Vital Bleaching Technique; by Van B. Haywood (1991) E-mail to Casey & Bakewell from White re: Question Bobby White’s Call Log Files: Referencing Whitening/Bleaching 2004-2010 E-mail to White from Reitz: re: Anything New? dated 3/2/2010 Letter to Ronald Owens from Bobby White: re: Welcome Letter & Training Information dated 7/8/05 Letter to Ronald Owens from Bobby White: re: Welcome Letter & Training Information dated 6/25/08 E-mail to [email protected] from Steinbicker: re: Question about Serenity Total Body Care dated 9/1/09 Two Buena Vista Smiles Advertisements – undated

CX389 CX390 CX391 CX392

CX397

CX402

CX404 CX411 CX419 CX449

CX450

CX452

CX455

17   

Cited Page Nos. 1-2

Appendix Page No.

1-2

1217

1-2

1219

1-2

1221

1-3, 5, 8 1-2

1223 1226 1227 1228

3-8

1230

1-3

1236

1-4

1239

1-2

1243

1

1245

1

1246

1

1247

1-2

1248

1215

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 18 of 366

Exhibit Number

Description

CX462

Open Investigative Files to Dr. Owens from Terry Friddle dated 8/12/10, see Sealed Volume VI below E-mail to Friddle & White from Owens re: Case Assignment 10-061 dated 4/6/2010 Dr. Ronald K. Owens' Subpoena Duces Tecum Response dated 9/30/10 Michael Hasson’s NCBDE Complaint Form Against Port City Tanning dated 2/20/2008 Letter to NCBDE from Michael Hasson re: Ms. Sharon Tran dated 1/12/2009 Memorandum to Members of the Board from Terry Friddle: re: Closed Investigative Files dated 5/1/09, see Sealed Volume VI below E-mail to Hansen from Bowman: re: June BOT Report dated 5/20/2008 [excerpt] 2008 Gallup Study of Dentists’ Attitudes Toward Tooth Whitening Products & Services – Summary Volume – September 2008 Letter to Michael Catanese from Carolin Bakewell: re: Tooth Whitening Kiosks dated 1/23/2008 E-mail to Mosley and White from Bakewell: re: Tooth Whitening Kiosks dated 3/24/2008 E-mail to White from Francis: re: Teeth Whitening Info Dr. Michael Catanese’s Response to the FTC’s Subpoena Duces Tecum dated 9/1/2010 Dr. Mark Hyman’s Response to the FTC’s Subpoena Duces Tecum dated 9/13/2010 Dr. Kurt A. McKissick’s Response to the FTC’s Subpoena Duces Tecum dated 9/3/2010 Dr. R. Kelly Kreeb’s Response to the FTC’s Subpoena Duces Tecum dated 9/9/2010 Dr. Michael Treman’s Response to the FTC’s Subpoena Duces Tecum dated 9/13/2010

CX465 CX467 CX476 CX477 CX478

CX488 CX513

CX524

CX525 CX542 CX599 CX600 CX601 CX602 CX603

18   

Cited Page Nos.

Appendix Page No.

3-4

v.VI 1713

1

1250

1

1251

1-4

1252

1-5

1256

3

v.VI 1715

49

1261

1-87

1262

1-3

1349

1

1352

1

1353

1-4

1354

1-4

1358

7-14

1362

1-3

1370

1-3

1373

Appeal: 12-1172

Exhibit Number CX605

Doc: 63-4

Filed: 07/06/2012

Pg: 19 of 366

Description

Dr. Jessica L. Bishop’s Response to the FTC’s Subpoena Duces Tecum dated 9/1/2010

Cited Page Nos. 1-4

Appendix Page No.

2

1380

2, 4 21-22

1381 1382 1383

1-2

1385

1

1387

1

1388

1-3

v.VI 1716

1-4

v.VI 1719

1-3

1389

1-17

1392

1

1409

1-4

1410

1-4

1414

1376

VOLUME V CX608 CX611 CX616 CX619

CX620 CX621 CX622

CX623

CX629 CX647 CX649 CX650

CX651

Dr. Scott P. Guice’s Response to the FTC’s Subpoena Duces Tecum dated 9/7/2010 Dr. Christopher N. Reese’s Response to the FTC’s Subpoena Duces Tecum dated 9/17/2010 Dr. Craig Q. Adams’s Response to the FTC’s Subpoena Duces Tecum dated 9/2/2010 Fax to the NC State Board of Dental Examiners from Luis E. Arzola, D.M.D.: re: Complaint about spa teeth whitening dated 9/11/2006 Investigative Memo to Terry Friddle from Andrea Smyth: re: Serenity Day Spa dated 11/3/2005 Unsigned fax: re: Complaint about Sunsational Tanning dated 1/28/2007 Memorandum to Members of the Board from Terry Friddle: re: Closed Investigative Files dated 7/16/2007, see Sealed Volume VI below Memorandum to Members of the Board from Terry Friddle: re: Closed Investigative Files dated 2/29/08, see Sealed Volume VI below Letter to Steven J. Osnowitz from Brian Wyant: re: Mall leasing history dated 9/27/2010 E-mail to Osnowitz from Feit: re: Teeth Whitening Inquiry dated 8/27/2009 Letter to Frank Recker from Lili C. Reitz, Ohio State Dental Board, dated 8/25/2006 Memorandum to Albert L. Partee, III, from Robert E. Cooper and Sue A. Sheldon re: Tennessee Board of Dentistry, dated 6/7/2010 Letter to Sandra Rowe from Thomas J. Balistren: re:teeth whitening dated 2/22/2005

19   

Appeal: 12-1172

Exhibit Number

Doc: 63-4

Filed: 07/06/2012

Pg: 20 of 366

Description

CX653

Expert Witness Report of Martin Giniger dated 11/26/2010

CX654

Expert Witness Report of Professor John Kwoka dated 11/26/2010 Memorandum to Members of the Board from Terry Friddle: re: Closed Investigative Files dated 8/25/08, see Sealed Volume VI below Memorandum to Members of the Board from Terry Friddle: re: Closed Investigative Files dated 2/15/08, see Sealed Volume VI below Memorandum to Members of the Board from Terry Friddle: re: Closed Investigative Files dated 5/11/07, see Sealed Volume VI below E-mail to Nelson from Nelson: re: Fwd: Savvy Salon dated 8/31/2010 Statutory Provisions Governing Membership Composition of and Selection Criteria for North Carolina Occupational Licensing and Regulatory Boards (3/18/2011)

CX658

CX659

CX660

CX814 CX862

Cited Page Nos. 1-9, 21-23, 37-44 1-33

Appendix Page No. 1418 1427 1430 1438

1-6

v.VI 1723

3

v.VI 1729

1-5

v.VI 1730

1

1471

1-37

1472

Respondent’s Exhibits Exhibit Number RX1 RX2 RX4 RX5

Description

Selected documents from Amazing Grace Spa Investigative file, Case 07-021 Selected documents from Bailey’s Lightning Whitening Investigative File, Case 08-133 Selected documents from Bleach Bright Investigative File, Case 08-029 Selected documents from BleachBright Investigative File, Case 08-072

20   

Cited Page Nos. 1-3

Appendix Page No.

1-4

1512

1, 5-7, 30-33 1-5

1516, 1517, 1520 1524

1509

Appeal: 12-1172

Exhibit Number RX6 RX8

RX9 RX10

RX12

RX13

RX14 RX15

RX16 RX17 RX19 RX21 RX22 RX23 RX24

Doc: 63-4

Filed: 07/06/2012

Description

Selected documents from BleachBright/Inspire Skin & Body Investigative File, Case 08-214 Selected documents from Carmel Day Spa & Salon Investigative File, Case 07-146 Selected documents from Celebrity Smiles Investigative File, Case 07-208 Selected documents from Champagne Taste/Lash Lady Investigative File, Case 07114 Fax from Larry Cook to Dental Board, from The Extra Smile, Inc. Investigative File, Case 07-146 Fax from Stuart Whiddon to Carolin Bakewell, from Fantasticians, Inc. Investigative File, Case 08-206 Selected documents from Florida White Smile/ Sam’s Club Investigative File, Case 08-083 Selected documents from Hollywood Smiles/Brandi Temple Investigative File, Case 04-188 Selected documents from iBriteExpress/Joe Willett Investigative File, Case 08-199 Selected documents from Lite Brite Investigative File, Case 08-132 Selected documents from Movie Star Smile Investigative File, Case 07-223 Selected documents from Port City Tanning Investigative File, Case 08-018 Selected documents from Sean Powers/Savage Tan Investigative File, Case 07-148 Selected documents from Serenity Day Spa Investigative File, Case 05-210 Selected documents from SheShe Studio Spa Investigative File, Case 07-026

21   

Pg: 21 of 366

Cited Page Nos. 2-7

Appendix Page No.

6, 9-10, 13-17 2-3, 7 1-3

1535 1536 1538 1543 1545 1546

1

1549

1-2

1550

1-2, 4-20 9

1552 1554 1571

1-6

1572

1-2

1578

1-7

1580

1-10

1587

18-19

1597

2-3

1599

3-5

1601

1529

Appeal: 12-1172

Exhibit Number RX25 RX26 RX27 RX28 RX29 RX30 RX31

RX32 RX34 RX35 RX36 RX37 RX38 RX39 RX78 RX82 RX83 RX84

Doc: 63-4

Filed: 07/06/2012

Description

Selected documents from Signature Spas Investigative File, Case 06-193 Selected documents from Spa White/White Science Investigative File, Case 07-020 Selected documents from Star Bright/Cutting Crib Investigative File, Case 06-114 Selected documents from Suave D’s Investigative File, Case 09-272 Selected documents from Sunsational Tan Investigative File, Case 07-120 Selected documents from Tom Jones Express Smile Investigative File, Case 09-049 Fax from Mike Doyle to Carolin Bakewell w/advertisement from Triad Body Secrets Investigative File, Case 08-195 Selected documents from WOW Whitening on Wheels Investigative File, Case 09-049 Newsletter of North Carolina Board of Massage & Bodywork Therapy Newsletter of North Carolina Board of Massage & Bodywork Therapy, Winter 2007 Newsletter of North Carolina Board of Massage & Bodywork Therapy, Winter 2008 Kansas Dental Board Newsletter Letter from Brian K. Bishop to Paradise Tanning Salon w/ affidavit Letter from Leah Diane Howell to White Smile USA Expert Witness Report of Dr. David Baumer Article: When It Comes to Tooth Whitening, Shoppers Beware News Report: Mall Teeth Whitening: Is It Safe?; New Trend in Billion Dollar Industry Article: Sarah Albrecht, What Are the Dangers of Teeth Whitening?, ehow.com

22   

Pg: 22 of 366

Cited Page Nos. 15, 25-27 1-19

Appendix Page No.

1, 4, 6-10 1-4

1627, 1628, 1629 1634

1-2

1638

5, 8 2

1640 1641 1642

1, 4-5 3

1643 1644 1646

3

1647

5

1648

2 1-3

1649 1650

1-2

1653

8-9 1

1655 1657

1-2

1658

1-2

1660

1604 1605 1608

Appeal: 12-1172

Exhibit Number RX85 RX86 RX87 RX88 RX89 RX90 RX91 RX94

RX96 RX101 RX103

RX115 RX116 RX117 RX123 RX128 RX129

Doc: 63-4

Filed: 07/06/2012

Description

Article: David Chandler, Dangers of Tooth Whitening Chemicals and Treatments Article: Julia Temple, Dangers of Tooth Whitening Article: Special Report: Hidden Dangers of Teeth Whitening Article: Teeth Whitening Dangers?, teethwhiteningreviews.com Article: Laurel Naversen Geraghty, The Dangers of Teeth Whitening, Prevention Article: The Dangers of Teeth Whitening Press release: How Safe Is a Bright Smile?, Green Facts Article: Barney Calman, It Seemed as if My Teeth Had Been Dipped in Acid; Now I Drink Coffee Through a Straw, The Mail Article: Harvard Health Letters, A Guide to Pearly Whites, Chicago Daily Herald Article: Teeth Whitening in State Needs a Dentist, Birmingham News Article: Andy Miller, Licensing at Issue; Dental Group Frowns on Kiosk Whitening, Atlanta Journal-Constitution Article: Salon, State in Pearly White Fight, Billings Gazette New Report: Sue Manteris, Should You Trust Your Teeth Whitening at the Mall? Article: Teeth Whitening May Be Health Concern News Report: State Dental Board Bans Teeth Whitening at Mall Kiosks Media Release: Magistrate Rules Against Tooth Whitening, Australian Associated Press Article: Magistrate Rules Against Therapist Whitening Teeth, Australian Associated Press

23   

Pg: 23 of 366

Cited Page Nos. 1

Appendix Page No.

1

1663

1-2

1664

1-2

1666

1-5

1668

1-2 1-2

1673 1675

1-3

1677

1-2

1680

1-3

1682

1-2

1685

1

1687

1-2

1688

1

1690

1-2

1691

1-2

1693

1

1695

1662

Appeal: 12-1172

Exhibit Number RX133

Doc: 63-4

Filed: 07/06/2012

Pg: 24 of 366

Description

News Report: David Wade, Curious if Teeth Whitening at Mall Kiosks Is Safe

Cited Page Nos. 1-2

Appendix Page No. 1696

VOLUME VI SEALED MATERIAL Complaint Counsel’s In Camera Exhibits Exhibit Number

Description

CX106

Closed Session Minutes from NC Dental Board Meeting in Morrisville, NC 8/10-8/11/2007 & 2/78/2008 dated 8/10/2007 Closed Session Minutes from NC Dental Board Meeting in Morrisville, NC 3/14-3/15/2008 dated 3/14/2008 Chart of Carolin Bakewell's Cases dated 3/11/09 List of Teeth Whitening Case Files Memorandum to Members of the Board from Terry Friddle: re: Closed Investigative Files dated 9/7/07 Open Investigative Files to Dr. Owens from Terry Friddle dated 8/12/10 Memorandum to Members of the Board from Terry Friddle: re: Closed Investigative Files dated 5/1/09 Memorandum to Members of the Board from Terry Friddle: re: Closed Investigative Files dated 7/16/2007 Memorandum to Members of the Board from Terry Friddle: re: Closed Investigative Files dated 2/29/08

CX109

CX270 CX276 CX368

CX462 CX478

CX622

CX623

24   

Cited Page Nos. 1-5

Appendix Page No.

1-3

1703

1-2 1-2 1-2, 5

1706 1708 1710 1712

3-4

1713

3

1715

1-3

1716

1-4

1719

1698

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 25 of 366

Exhibit Number

Description

CX658

Memorandum to Members of the Board from Terry Friddle: re: Closed Investigative Files dated 8/25/08 Memorandum to Members of the Board from Terry Friddle: re: Closed Investigative Files dated 2/15/08 Memorandum to Members of the Board from Terry Friddle: re: Closed Investigative Files dated 5/11/07

CX659

CX660

25   

Cited Page Nos. 1-6

Appendix Page No.

3

1729

1-5

1730

1723

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 26 of 366

BRA(;RY PIUVATE INVESTIGATIOl"'l'S Jos.!!'e 0. SRAC:Y P. O. Be:! 1!&l D...w-, NC 18036 OFFICI: I PAX (70+-7I4-I38l) MOBILE (704-877~m!) 1I:IIWlIbr!lm'Dl'i'"aro!Iua.rr.C.S., ... . . . UlIMIlI\ P. uum,c-_

c. WAYIIJ: Rou.A!iD, D.D.S. BaAl) ClIIOltGAI'!, D.D.S.

I\'ULUS S. BALL, II.D.H.

November 26, 2007

Mr. Sean Powers

611 Three Oaks Drlva High Point, North Caroiina 27265 NOTiCE AND ORDER TO CEASE AND DESIST Dear Mr. Powers: Tile North Carolina State Board of Dental El
1

a.

CX0096-004

Sensitivity 1:10 hot Billd cold food or o:r hE,ver&igell bE,ver&igell iEl IXlmll1(,n CEten performed plriol'lned IllUely Ilately iontl elifec:tively for yeBl1~ aud iont! and CllIntiquetl Cllr. please notify our office at 8(J().224-3S29 lIIld intft'ledi ....!y delete thii ffliiiii1 T.nank youi

NCBOARD826

1056

CX0108-002

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 44 of 366

NCBOARD827

1057

CX0108-003

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 45 of 366

MSDS: MATERIAL SAFETY DATA S1-4ro,r MSDS Name:

titeofproch&ct: ComployldelltificatioD



W,",'TESClence

Sp. wliitetHtbwtlitenibfPld Deat&lwhiteDiq

White Science is Wett Cra ....riDe R.o.d Suite 51.,. &,well. GAaoO?:;

Eme,.ucy COIlUct: low aDtt~poitoa center S;CTiQN ii, COMPOSITION Chemjc· 1 Nama

CAS NpmJrr

NIA

Eye.:

....., CRIe dam.ap with uleeratton of the eorae& awl/or irritttio-. of the ~ lid. ewld oeca.r. PrttIODpd eoatact with th'll e'f~=-7~4~~damap.

I.JUaala&n: Small ~ of~ p~~ ~~ :!:..~~p~rrlil" .h...-,.ld uot'~iW-l..u.iiiiJ'. iDprioD. oiia.tJe11:DOUllU may caue initatiOll of the upper p.ttro-ll:IteI1iD.a1 tnet with paiD.. 111;",". conattpatioa. clianbea. dUteaaian of the ~'l!om= wd/... "~p. (Que to iiilenlioD of OZJP11land potential rid:: o(.wf'oett!oI1.

Eya:

InunecJ.iatdy nub eye. with pleat,. ofwaulr (or at leaH IS uUautel. Gel medical a14 withoat deb,.. prererably fJ'GJ:I1 aD ~~k!:t...!t.

Sk!!'l:

Iqe.tlon(onrdote):

!t~ ~ _kia _itb. pIeRi1 J ..ier torlll.u:, •• t 15 mi:mrtaa. 'rAe wbtti&hdiseolontionoftb.e Min iI DOrmalan.d will diaappear. If DOt. COQQct J'OUtpliy.icilia. IllIIOntbaDt.benpeutieQlWQlltoftbe~"Y!~lln~.d..o1!!kb...'r~Ql;t;.tariiideuWiil1i]V'U'"pb.y.iciaD.

Do .not i.JIduee l'OlDitiDf.

GeD&!raJ:

Gel. UiaotOlmmabJe. TbefOUll ilicomhll.ltibiematerillllld /!W.IU. wbenhuraial. hrteJue beatlnd: de!llfla:moke. Fire h"".'!'~ !1mo.!!~ :!:!ie td!-ec=.~,;,uu:d bi'AOhl.ilj iippiitIhU.

Pl.aah point: 'I'he loam cab, whu bhted. tnth aad ll.lmmabl. dteomplHitloD prone,. eaBh. paerated.. tll.l fan. dlltCOmpoallinl'! p•...1_ta lib .....-kiihl&ck. cuboa.~. eariIoa dioa1de. p.HOA ~aad.1iliTopD. ~f1:Oduct. caa.he p:aentcd ia.Yariou eoacemrarioll.l ~ Db tM ~~l'I'Ihn.,...!f.1!:!!! _.l4H __ ••.1= =r:oa..~ i ..... llaii-" pnerned itrO.lb'll"l.dlt coat.ia. fI.me ret.lr1i ..nta. NI'PAJ\altAi:

N'lA

ErplotionlimJ.t.I:

HlA

Eltmil1ltt every poI.ible lource of IpitiOI!. (gp~!! 6~. !p!.rl!:!, !!!!cl!:!l!!i. ;:t:;:. ~;~.:=;e.ill p~iMiu.iiel. Arvid contact wlth .ldo.ad eye&. trae proper penoa.a.I pf1)teetm equipment .. ind1c.t.ted in Section8.

Spilt.: Dtb tpilled product U lIUIeh., pouible with inen material. Collect the aptUap ill double. ndtahle dUpauJ Mn~ t,;,!.:lc;-;, Cl.w.i:;. ~ iii, liipill ••• JOOIl U ~ie. UltDJ aa.1.D.tm ablOmem material. Forthe relDGYll ol~ WU1e prodqcc, ~_cbapter 13. !\elida i. to bew..hed down with plenty ",~~ p!~!!!.! ~tt1 ~fpred.=t ia: p-..!;lk; ....ta'. K1IJtlD or loil. (.;ollect matetU!.od dilpoae orin. manner couaiIteDt with toc.l n!'PatioDl.

HaDdUnr:

kep iuaealedpacbce until immediately beror~ we, AYOidpJ CODuettllJ eye•.

SfC)r.ge: Store t.a,cooI dry place. Avoid expolare to dire
.A; [email protected]

Q: Is It safe? k Peroxide-based teeth whitening has been employed by dentists fur over a decade, and over-the-ooU!!!er products such as Crest WhiteStrlpe are used by miDlolll of people worldwide with /JttIe or 00 aide elf"",", We don1 recommeod the UghtWhite® proceso fur anyone onder 16 yean of l!!e or pregnant or ~ting

women. Q' Vv'hy shouid I consider haviDg a whiter smlle? J..: Studies h:ve shO"'"~ thit not only do people who have whiter teeth iook younger than people who don't, but that there is a cc..i'.....~tiQn between high seii-esteem and a white, confident smile.

A; In most cases, no. Since our specially formulated peroxide gel is on your teet"..h for Oll.&'y 12 minutes tim~ our clienb rarely experience sensitivity. Product:! th!!t have pctMa!um nitrate in them like

at ii

Sensodyne Teethpaste offer instant reI!ef fur teet..!! senoilMty. Q: I have eaps on my front teeth. will LightWhiU® work on them? k No. We doo't recommend whitening fur caps, bonding, or veneers.

NCBOARD838

1068

CX0108-014

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 56 of 366

WhJteSmile Q: How long will It last? A: Simple: W. wbite!! your teeth,you stain thelli. By following our post whitening instructions, your

teeth will always be lighter tJ.. .... they "'-ere before. We generally recommend touch up applications every 3-6 months; or our rec.unl.Dlended maintenance program.

Clients who smoke cigarettes or d.....i.nk lL6e quantities of coffee, tea, red wine. cola, etc. wiD increase the probability of stain buildup on their teeth and ""'"' likely need to touch up their teeth more frequently_

Qt What Is the process? A: After gettlD& comfortable in the chaB. you and the Whit-iftg T~k'.Hi (Vv'T) will agree on your ~oefureiO shade on the VrtaPan teeth shader rmdtL~ ,!I',.and:.rd). The \\-"1" will ihen present you: with your custom tray. The UghtWhite® gel is p~ in eaeh cavity a..".. of the mouthpiece_ You then place the tray back in your mouth, put Oil your protective amb-...r SUng'"'iCi. aud the w'T wii1 tnm on the WhiteUght whitening light for 12 minu~_ It's thai. ea3"/_ A.zter the pnx:eUure, yoo and wr both agree on the "after" shade on the V1taPan seale,

Q: How" tbt. different from BriteSmiIe and Z--...? A:. The V.1JiteSmJJeUSA process is very similar to BriteSmile and Zoom (pe.t·oxide 3;... ,,1 "nith LED lighti, but there ate a few key dHfenmces including -self administra.tion·~ perc.entage cfpercD3e, and wOBt impurnmUy. price. Qt Don'tycu ha-ve to be a cientist to whiten teeth? A: No. The FDA has approved the use oflower peroxide percentages for over-the-rounter uae. Since our product Is ""If-."mlnl...e:ed, it's really no different 1han wbat yoo can do at home. The key ~ is the 1l8e of th~ 'lg"fWh!=® whitening llght and our photo-iDiliator technology to speed up the pr".....· into ~ minnt... We do tacoUlii:leiid reguiar visitJJ to your dentist..

Q: Do you whiteD the top. and bottoms? A: Yes. Our unique tray covers the tops Slid bott'-'!!!.! aftha tw..n. 'I'his pttJgtiu. CCllllt"'UB of IIPPI1' 1lJ1Ii1 Iower teed., prclVi"'ill~ contacl. and CClIlllj.Jet;e cov,.rage witbClUt, ~... meaocr hasile of strip., Ji'or cliilli::>el UIY ,

If you wiii be using the optional Cart/Stand, assemble It before attempting to install your bght The cart/stand is packed In a large carton. 1.1 Base ilsambty. Open stand carton by carefully cutting the tape around the perimeter.

Remove the verticai section and top sheif and set aside.

Using a pair of scis:iors, ca...·. duUy remC". "e . the w-rapping from the 5-spoke base. Aitemate1y, remove the casten and slide the wrapping off each

spoke, then reinstall casters. Set base on floor, CMLefi doWti.. F"Jp the caster iocks down to iock the casters so the base does not roll

-2-

NCBOAR0847

1077

CX0108-023

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 65 of 366

1.2 Upright section. Unpack vertical pole. Carefully insert blaclc fitting on bottom ofverti.... ' nn1". int"n 'I1M"A haC! .. ' rnu.h ................ u..:.t.. ~-.- - _ ......_..., y ...... ua

c --

&

~"en, rt-~; press-ute

" " " " .... "

" " ...

until the top of

the fitting is snug against the top of the base.

1.3 Unpaclt top shel£ Remove eye bolt, washers and wing nut from pole and set aside.. Set top shl'!lf on tDp of nnl,.. 'lIlttl'ftt ........ l.. .... I... : ... .. 1... ...It' • .....: ...L r--' ..........- "'.... 'u"'........ "" .. holes in pole. IniClt eye bolt through ----e~

A

1o.U.

hoies with washers positioned as shawn and secure with wing nut. DO Nor OVER TIGHI'EN! Your standi cart is now comniete.

~

.

• • DO NOT OVER TIGHTEN WING NUTI

,A

Manual and hex wrench storage. Your standica..-t is the ideal place to keep handy this manuai and the hex wrench. Use the enclosed tie to fasten them to the eye bolt that secures the top shelf to the vertical

pole of the SH'ld/cLrt.

-3-

NCBOARD848

1078

CX0108-024

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 66 of 366

i j n n.::lrid nf"l I in hi" t"" I "'::::1 L...I'::::J I 'l. -

I



\.A " - ' "

Mounting to Stand 2.1 'frave' case. Your DarT .ight SK is packed in a protecth"e tr....e! case, which is conv-eniefit for transporting your light for out-calls. Set the case on a flat surl'ace with the Daylight SK logo reading correct from lett to right. Open the: case by pulling up on the latches.

Lift lid. Release Velcto tabs and lift divider shel£ Store shelf in lid of t.h~ case

~mporari_1y.

Lift the convoluted foam pad. Your DayLight SK is stored below with its power suppli.

-4-

NCBOARD849

1079

CX0108-025

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 67 of 366

2.2 Attaching light. Remove the light assembrj_ You must attach it to tr.IE: top shelf of the stand or to a suitable flat, secure surface. Open the clamp by turning the knob countetclockwise until it cIears the surlace to which you want it attame-i Tighten the ...1amp to the fTII .......... ...:: ... _ . . . & .............

~

--o to"'e

.... ~-r-~ L __ ...... t1ffiifi Street. SuIte 101. Columt>wo. Oblo 43207·4041 Phcme: (614) 4GG-3834 a: Fax: (IHo&) IWI. !!Bao ~.eoa ;-.lJtn~: eWqmebsi9sp!·llI,tt M'll'

--

Frank Recker Esq. Frank It F~.kAr &: ~uat6 Co. 1700 FOUl-tn &; Vme Towu . -01. Yie,t FelSlB, Street~Cincinnati, Ohio 45202

- -"

~

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The Bovd haa !'eCe2ve(i yo'.!!' letter dated AUifUit 28, 2006. AitI1r reviewing the inlonnatkJl>. provitl"'" i."1 yO".l% letter, it ia the position of the Ohio State Board of C"'n ""'letcl...."8'J that so long as me customer applies the pt'Oduet: to thernselves, ti'o..ere would .ppear to be no Violation of !hAt Ohio ReVisI!d Cod" @ection 4?13. HCv.Tver, our ofike would recommend tIuo.t any advertL.lIeIl\ent fo~ t.'Ua product in a 9Ilion should reflect the Iollowing. Wlill!! !:.~e cu..-tomer WO\lll1 be under the supervision and/or advisement of !! steff member; t.'lAi piVduct is to be applied ONLY by the c:ustomer, to

t.."!!1l'mves. Ii you have any questions, please contact my uffice at 6146'4 6139.

KLMIsr

NCBOARD866

1096

CX0108-042

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

NORTH C.i~...ROL!N..~ ST~-\TE

Pg: 84 of 366

BOAP~

OF DENTAL E~1\m~ERS

JOSUii s.. BUii1iiLUi, D.D,S.. Praideat W. STA.1iof HA.lUl~ItNfY, D.D.s.... SiJCi1iiii7~TI'CUwl::Il" STAN'L.tY L, ALL~. D.D.S.. p..-$t Pre:ident ZANNI); P.

EI'IJU),

ClJFF01U> O. FEINGOLD, n.ns

RONALD K. OWENS. D.D.S. C. WAYNE aOLi.,.Ai'i.tu, V.V.S. N!PLUS S. HALL, lUtE.

c:o..um.. M..,.,.,

BOBBY n. WJlITE, Chief Openli.... Qffiw

Feb. 13) 2007

¥lbite Science 45 West Crossville Road, Ste. 514 Rosweii, Ga. 30075

Dear Sir or Madam: It has come to the attention of the N.C State Board of Denta! Rxaminers that repre.sentatives of your :firm h::tve sold andior attempted to sell va..~ous teeth whitening systems to non-dental professionals in North Carolina, S"u.ch as spa and salon owllers. We gather t.l).at you may also be selling disttiblttorships.

Please be advised that, uudet North Carolina law, any process that "[r]emoves .cains, ac
, Home Addrw (>I1'Cct, City. s-. zip Code)

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NcaOARD1707

1103

CX0111-006

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 91 of 366

NORTH CAROLINA STATE BOARD OF DENTAL EXAMINERS RO;o.iALD K, OWENS, D.D.S., President C. WAYNE

HOLL.-\.~D! D.D.S.~

JOSEPH S. BURNHAM. D.D.S. BRAD C. MORG,,"", D.D.s, MILLARD w. WESTER, Ill, D.D.S. JEN:' ..... _ • • • • -. ............... , ' .. r .,... ................... , .......

+,",I!!!!. h., ........... _ .............................. - -- :,-......,." \1 • .., IIUIIICU I ,,'I;I'WU', !bIUI I I;:' UI JdW::»,

"(10) Peiforrns or engages in any of ihe ciinical practices included in the curricuia of recognized dental schools or colleges."

507 ArRPORT BOl'LlZ';::"Rn, SLITE iOS' viORRiSVILLE. NORTH CAROLINA 17S60-8100 TELEPHONE (919) 61S-8213' F.\X (911J) 6,8-8472' [.VlAIL: jDfo"i\nc'h~nt.!l;thll..rrl.n~"· ~WW_!!~d~!H!!!h!).l!H"d.()=--g

NCBOARD1972

1110

CX0123-001

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 98 of 366

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Mr. Joe Willett September 24, 2008 Page Two

The North Carolina State Board of Dental Examiners is the state agency charged with regulating the practice of dentistry in North Carolina and is the proper agency to conduct this investigation. The Board may use any legal means at its disposal to conduct this investigation including bt.rt not limited to, intervie'vv5 with current and forrnei n-::ltic.ntc cllr\,o.iII ...... n.................. +........... i ............. $ ...... ..l _ _ _ •• __ ... ~""""'''''' mQI OJ IU Lilli;: IIIIIII~ VI UIIUCI\A)VCf t1ytjrll:::;. j

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The Board requesis that you cooperate in the current investigation by calling the Board's office and arranging to be interviewed by the Board's investigator and by submitting a written response to this notice and order within fifteen (15) days of ti1e receipt of this letter. Sincerely, .....

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1'111 l . I V (1..-11.

'-""'tI-"~O'-f::.Casie S.-Goode Assistant Director of Investigations TUI::

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BOARD OF DENTAL EXAMiNERS

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Case Officer ~AQ

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1111

CX0123-002

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 99 of 366

NORTH CAROLiNA STATE BOARD OF DENTAL EXAMINERS JOSEPH S. BtJR"iHAM. .. D.D.s. BEt~D C. MORG . .U'''!. D.D.S. MII.LARn W. WESTER, m; O,D$. JENNIFER A. SHEPPARD, R.D,H,

RONALD fC OWENS, D.D.S., Prestdent WAY~fo: HOtLAND, D.D.S., Secretary-Tre:l.Sllrer

C.

W.

ST.~N

lA;-.I~lE

HARDESTY. O.D.S.. Past Pmident P. [FrRO. Consumer Member BOBBY O. WHITE, Chief Operatlons Officer

507 AifPOrt Bou~vard Suite 105 Morrisville, NC 27560 Phone: (9i9) 67fS..8223 F~(91S)67~72

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Phone: (2S2) 237-3118

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PLEASE PEP.FORM cp-.se REV!EW ON THE ATTACHED COMPLAINT:

CASE REVIEW COMPLETED

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CASE ASSIGNED TO: (

jj04

J ------~i~IER, Ill, D.D.S. KENNETH M. SADLER, n,D.S. .JENNIFER A_ SHEPP..... RD, R.D.f!.

C. W.\VNF; HOLLAND. D.D.S., Pre~;,jcnr BRAn C MORGAN, D,D.s" S~cretary- Tre~I~IJTt">r RONALD K. OWENS, O.D.S .... Past Pre~ldent OR. JAMES B. HEMBV,JR., CO[l1>\Jrner Member BOBBY D, WHfHc, ChlCfOpmltlons Officer

December 14. 2009

CERTiFiED iitiAiLiRETURN RECEIPT Ms. Heather Wiecek Buena Vista Smiles 773 North Stratford Road Winston-Salem. North Carolina 27104 NOTICE OF APPARENT VIOLA.T!ON AND DEMAND TO CEASE AND DES!ST Dear Ms. Wiecek: The North Carolina State Board of Dental Examineis is investigating a report that you are engaged in the unlicensed practice of dentistry. Pursuant io N.C. Generai Statute § 90-41, practicing dentistry without a license in North Caroiina IS a misdemeanor. The Dental Board hereby demands that you CEASE AND DESIST any and all activity constituting the practice of aeniistry as defined by North Carolina General StatL1es § 90-29 and the Dental Board Ruies promuigated thereunder. Specifically. G.S. § 90-29(b) states that ..... [a] person shall be deemed to be practicing dentistry in this State who does. undertakes or attempts to do, or claims the ability to do anyone or more of the following acts or things which. for the purposes of this Articie. constitute the practice of dentistry:

(2)

Removes stains, accretions or deposits from the human teeth;

(7)

Takes or makes an impreSSion of the human teeth, gums or jaws;

SU7 AIRPORT ROlIU:VARD,SUln 105· fI.'fORRfSVILLE, I\ORTH CAROUNA 27560-8200 TEU_:PHONE (919) 67K-li22" P,,_x \9t91 "i~.~~l • ~~V,JL ;nf"!"'iiqktl!)t~· www.n("{i~lltalbo~rd./)r-g

NCBOARD6075

1118

CX0155-001

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

NORTH

C~t\ROLrN}~

Pg: 106 of 366

STATE B()ARD OF DENTAL EXA.lVIINEf{S

Co \~!AVNE HOLLANti, D.D.5., President BRA}) C. ,"fOR.GAN, D.n.s .. S~cre\:uy.1"rea5uicr RONALD K. OWENS, D.D,S., Past Prel;i,ient

W. STAN HARDESTY, D.D.S. MltLARD W, WESTER, III. D.[}.S. KENN£'i"H .VI. SA IlLER. D.D.S.

OR. JAMES H.lfEMBY,JR,ConSUJller Memi":er

JENNlFERA. SHErrARD. R.D.H. nOBBY D. \\1I1TE, Chiel"OperJliorh Offirer

Page Two

(10)

Performs or engages in any of the clinical practices included in the curricula of recognized dental schoo{s or colleges.

(11)

Owns, manages, supervises, controls or conducts, either himself or by and through another person or persons, any enterprise wherein Bny one or more of the acts or piactices set rorih in [G.S. 9029(b)(1) - (10)].

(13)

Represents to the public, by any advertisement or announcement, by or through any rnedia, the abiiity or qualification to do or perform any of the acts Or practices set forth in [G.S. 90-29(b)(1) - (10)].

The North Carolina State Board of Dental Examiners is the state agency charged Wit~, reguiating the practice of dentistry in North Carolina and is the proper agency to c-onduct this investigation. The Board may use any legal means at its disposai to conduct this investigation including, but not limited to, interviews with current and former patients, surveillance, and the hiring of undercover agents. The Board requests that you cooperate in the current investigation by submitting a written response to this notice within fifteen (15) days of the receipt of this letter. Sincerely, /)

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specialize in orthodontics, requested. th.at the Board of Dental exarninen consider and implementing a new radiology certification ce.rtification course for dental assistants in extra-oral radiology. As the statute now stands, in ordet for dental assistants to gain radiography certification they ate tequited to take a comprehensive intta-ow radiology course. However, orthodontic practices focus primarily on extr..-ow radiolOllV. radiology. In th;ir their dental assistants both inttaradiology. opinion, should to be trained in inti..and extta-oral radiol~. de~

~

-_. --

--- --

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The Board Board noted noted that th~t th,. rnrn""nnttv College r,...l1 ..,.... system ~~r.. "'" ........ ..,:I""",,,, ,olIf't; .............. 11.-.+.. 1...... 'h.,... ...h;, .... ~ l-. ...... : ..... The th~ Commnnity does :m excellent job of +_ teaching basic _OLLA. - ................................ .................... M,.l1nn-t'Gnhu ,olIf't;.rI _ ........... .......... 1 ..... _ _ l.. ...... .... 1... __ ___ _,.. ...... __ L ____ =__ .t'''' ....... t!i''' ... ----er*-t" ...., skills ... _ - ........ - .............. - ........................ vlS..... ....... V.l becoming UI;\.Vl.LW..&g fa.miliat radiography and extra=oral radiography then becomes ....a. .l..L.l4&LLt;;;.L rn.atter of u.-ith different machines. Follow-h~ this discussion, the Board deteIlllined that training in eX1rA-otal radiography could be best dealt with by in -office training since extra-oral eXlrA-otal radiograph equipment may vat}' vary from office to office. Board staff was ditected to respond to Dr. Zaytoun's inquiry. ----~

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Approval of Boatd Meetinl! Meeting Dates Dr. Hardesty [Item #11J proposed meetL'lg ~Q tes for 2008. Dr. Bu.tt"'llam. Board reviewed prop-;'sed rneetL'lg ~~ Butr'llam. tnade a motion to approye the proposed dates v.rith the noted revisions. Dr. ~{org-..n Seconded the motion, ,.....,,; .............. ... ...11........ .... __ 1 __ ... which passed by, ~lI;;n~-al consent. .... t'a.;J>:I ............ .. .... UJ.J.:icu ... The Th;

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Ptofessiona! Association Renewals

Dr. Morgan

NCBOARD1525

1138

CX0206-005

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 126 of 366

NORTH CAROiJrr~A STATE BOARD OF DENTAL EXALViI~'"ERS BENJAMJN W. DROWN, D.D.S., President S'fANLEY L. ALLEN. D.D.S., Sef.Tt,:wy.Treasurer C. WAYNE HOLLAND, D.D.S., Past Preftidmt £.ANNiE P. EFiRD, Consumer Member

BRAD C. MORGAN. D.D.s. JOSEPH S. BURNHAM. D.D.S. W. STAN

HARDE~'1Y>

D.D.S.

NEPLUS s. HAIL. R..D.ii. BOBBY D, WHITE, ChiefOperationli Officer

July 8,2005

Dr. Clifford O. Feingold 153 Smoky Park Highway, Suite 4 Asheville, North Carolina 28806 Dear Dr. Feingold: Congratulationsl We would like to personally welcome you to the North Carolina State Board of Dental Examiners! Your task as a member of the Board is to help ensure the dental health, safety and welfare of the citizens of North Carolina. The Board, as you are aware, licenses dentists and hygienists and is responsible for investigating any complaints concerning dentists or hygienists licensed in North Carolina. These are the major functions of the Board, hut you will find thai a nllmber of other issues are addressed during Board meetings as well.

You must begin your term by taking an oath of office, which we plan to have administered at a formal ceremony on August 19&', during the scheduled August Board meeting. You will be given a copy of the oath and a copy will remain In the Board office files. To assist you as you step into this new role, I have enClosea several items for your review. This information inciudes ihe Board's meeting schedule for the remainder of this year, a iist of current Board members and staff aiong with their contact information, a map indicating the iocation of the Board office in Cary, a copy of the Dental Practice Act, the Board's Byiaws, Personnel Manuai, several months of past Board meeting Minutes, information on the upcoming AADE meeting in Phiiadeiphia, a sampie of the Board's expense form, the iast iwo Board newsietters and a copy of the investigations Manual. Once you receive this information and t-!cjve an opportunity lo review ii, pi ease feel free to contact the Board office with any questions.

Please make note of the Board's'website, which is www.(](;dentalboard.org. TI-le webslte is very' helpful in providing information to the publiC. It IS full of information regarding every aspect of the Board's operation and is updated as often as needed by the Board staff.

EXE-C!..IT!V! OFFlCE· 15100 WESTON p.... RKWAY, st!!'fE Hn • CARY, NOR:" C,'\ROUN,A. !"ISH TELEPHONE (919) 6'8-822.' • FAX (919) '7~11. EMAIL. ~~. WWW.ndilntalboard,OoTg

NCBOARD004638

1139

CX0219-001

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 127 of 366

_---- ------ _.. -- -..... ..... --. ... t'KUt'U~I:U I U

-_ ..... INVE5TIGATIVE FILt:5

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CLOSED TO:

MEmBERS OF THE BOARD TEAAYW. FRiDDLE - DEPUTf OPERATiONS OFFiCER NOVEMBER 14. 2006

FROM:

DATE: 1)

DR. JOSEpH R. MOORiNG· [#U4-2iiij This general dentist was advertising in me yeiiow pages under me heading "Dentists Orthodontist.· Upon receipt of the Board's ietter, the raspondent mainiained that he was unaware of the listing, but agreed to remove it from the next edition of the teiephone book. Upon review of the newly published yellow pages, the Investigative Panel found that the respondent had removed his listing from under the specialty heading. In addition, all other listings appear to be in compliance with Board rules. Tha InVflstiaativa Panal reouests that this file be closed with a letter of caution regarding th..~ with --- ..i.;.:,ti~;;;;~~~~;"'n;;'ibilitv -_._---- ._-....-- ._----._" io -- make sura all of his advertisements are in compliance . Board rutes. --------

2)

STEPHA.~IE

n ... IJ_ ... '-'I 12 '='11 l"tel1

R. KEITH

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---

BR!GHT WHITENING

-t"-t, &ov ?~ I'\ •• 'r ....... nfFiJ"'G rAl""Aiw:arl ...v ....... ....w ..... _ ...... _

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were being offered at a kJeai haif sakn,. The peiSOn listed in the advertisement maintained that she worked ai iii dentai office biJl had started the tooth 'h'hitanir.g company to suppiemem ner income. The respondent stated that st"t6 takas t'ia impressions, sends the impressions to a laboretory in Fiorida where the bleac.'ilng trays are fabricated. She then deiivers the trays onca they are returned irom the iab. On May 13,2006, the Board hand-dellvered a cease and desist ietter to me respondent The respondent agreed to cease the prectlce of taking impressions and submitted a Liability Waiver" that all clients must sign which states that all impressions are to be made by the client. Based on this information, the Investigative Panel recommends that this file be closed. No additional action is warranted.

3)

OR. ANTHONY J, M!CHI"LAJ(IS. [#O6-168} !n Jut}' of this year, our offlc-e rec-eived an anonymous complaint from a man claiming to be a friend of one of t~e respondenfs hygienists. Acc-ard!ng to the caner. the dentist was _If_un ......... .., .... -.+ ... 1 "'4"4";~+"""'+ ........arf","," h\l6"tjar'\.t:ro f1lnMinnC!: inl"hu-tinn Qr.:::IlinnA ~nt1 rtAAn ClIIU,",III'i::j CI U'CIIII.G.I Clo;t~I~I.G.II~ '''"' "''!iiJI' I,,",' '1' "1:t11'-"'" ........................ -.--••• ~ ---... ---r ...,1 ___ 1___

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Tna respondent denied the aiiegations and expiained that there wei6 two other dentists in the office aside irom himseif and mat they empioyed three fuiHlme hygienists. He

3 NCBOAR01028

1140

CX0235-003

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

l'"~ORTH CAROLli'~A

Pg: 128 of 366

STATE BOARD OF DENTAL

BRAD C. MORGAN. D.E).$., PresirJenf C. WAYSE HOLLAND, D.D.S., Secretary~Trtaslirer DJll..M.A H.. KiNLAW, V.11.S.• f''l$! F'resiClcnf

EXAl\IIt~ERS

K£NNF.TH R. PHrUArs. D.O.S. MICHAEL G. JUSTICE. O.D.S. STANL£Y L. ALLEN. D.D.s. NEPUJS S. HALL. ItD.If.

June 26, 2003

Dr. Josaph S. Burnham

2912 Maplewood Avenue Winston-Salem, North Carolina 27103 Dear Dr. Burnham: congratulatlonsi i would like to personaUy weicome you to the North Carolina State Board of Dental Examinersi Your task as a member of ihe Board is io heip ensure the dental health, safety and welfare of ihe ciiizens of North Carolina. The Board, as you are aware, licenses dentists and hygienists and is responsibie for investigating any compiaints concerning dentists or hygienists iicensed in North Caroiina. These are the major funciions of ihe Board, bui you wiii find that a number of oiher issues are addressed during Board meetings as weiL

You musT begin your term by taking an oath of office, which we plan to have administered at the August Board rneettng. You witi be given a copy of the oath and a copy will remain in the Board office fiies.

To assist you as you step into this new role, I have enclosed several Items for your review. This information includeS the Board's meeting schedule fOi the remalndei of this yeai, a list of current Board iT'~mbeiS and staff along with Uieir contact infonnation, a rnap indicating the locatiotl of the Board office In Carj, a copy of the Dental Practice Act, the Board's 8yl3\V5, Personnal Manual, savaral months of past Board meeting ~v1inutas, information on t~a upcoming MDE meeting in San FranCisco, a sample of the Beard's expense form, the last t..,-,o Board nev...'Slatters and a copy of the Investigations Manual. Once you receive this Information and have an opportunity to rcvicvl it, please feel free to contact the Board office \·v!th any questions. Please make note of the Soard's; vJsbsite, which !s Vr".ANJ.ncdenta!board.org. The website is very helpful in pro1liding information to the public. It is full of information regarding every aspect of the Board's operation and is updated as often as needed by the Board staff.

EXECUT!VE. O!'P!CE '15!OOWL~ON !"••_lU n-.: '-I___L....... ""1" ..'lR ·lU ..... •.. o am II .1'11; J.v.I.III1;Il -'vvv I !,:;; ·L~S!'?a~. I u:; ~-.J~1o:i-" ... '"

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proof that the Beard of Dental EXamlneii will approve this. i have several Develope,.. letting me 1t_1'lOW that !.~!s use fa Ufegal In seve.-al states and ,,'-.at their operators have been shut down In their malls.

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'rs....\\7_..- ' Hel'l! Is the ;nema for tile CeleiIrity Smiles (SouthpoInt Mall) Teeth-whltenlng > cr- (07 w2(0). I w-a5 abie to serve the Cease and DesIst Order to Ms. > Hea~ 'fait.. :>

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UrPe Dem~, MA Iit.esttga-toi" :> NC Stat.. Board of Denim Examiners > 507 AJrpo."'t Boulevard, Suite i05 > Mo.~1ne, Ne 27560 :> 919=678..gm at 178S :> :>

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NCBOARD177

1199

CX0350-001

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

NORTH CAROLINA STA:I ".

Pg: 187 of 366

BO.A.~1ID

W. :TA.~ •gAJUlL~. ii.D.s.. Ptaideat RONALD I(.

OF DENTAL EXAI'YITh'ERS CLlFJ'ORD O. FEINGOLD, D.nS

owvm. D.D.s., Sacnwy-Trcuum

c. WAYNE ROLLAND, !lD3. BRAD C. MORGA!(, D.D.s. NlPLUS S. JIALL, R.D.H.

JOS!!'H !. !!!..'R.~~ D.n.s.. P"-.. iTciidcai: UNNIJ, Po. EF!!I.D. ~.:'J.'n..'"T M::+..ber

November 20. 2007

HAND·DELIVERED ~v1s.

Chiistiane Dotson Ms. Sherry Nelson Celebrity Smiles c/o The Streets at South Point 6910 Fayetteville Road Durham. North Carolina 27713

NOTICE AND ORDER TO CEASE A!'!D DESIST Dear Ms. Dotson and Ms. Ne!son: The North Carolina State Board of Dental Examiners is investigating a report that you are engaged in the uniicensed practice of dentistry. Practicing dentistry without a license in North Carolina is a crime. See (NC General Statutes § 90-40 and §9040.1). You are hereby ordered to CEASE AND DES!ST any and all activity constituting the practice of dentistry or dental hygiene as defined by North Caroiina General Statutes §90-29 and §90-233 and the Dental Board Ruies promulgated thereunder. Specifically. G.S. 90-29(b) states that .... ·A person shall be . deemed to be piacticing dentistry in this State who does, undertakes or attempts to do, or claims the abiiity to do anyone or more of the following acts or things which, for t",9 pUl~ses of this Article, constitute the practice of dentistry:·

"(7)

Takes or makes an impression of the human teeth, gums or jaws;"

1;(10) Performs or engages in any of the clinical practices included in the curricula of recognized dental schools or colleges."

!i01 AIRPORT 8OULEVAJtD, sum 1M· MOP_It!SVU"U:.. NO"'I II CAROLINA 17~0CI TELEtHON!: ('I') 6'Wlll· FAX (91f) 6' ...... 72· EMAIL: 'g(deakn"IM.nt.pIY. _,~~ot,,!!t!,!~e..""Il.=~

NCBOAR01,s9

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Ms. Christiane Dotson Ms. Sherry Nelson November 20, 2007 Page Two

The North Carolina State Board of Denta! Examiners is the state agency charged with regulating the practice of dentistry in North Carolina and is the proper agency to conduct this investigation. The Board may use any iegal means at Its disposal to conduct this investigation including, but not limited to, interviews with current and former patients, surveillance, and the hiring of undercover agents .. The Board requests that you cooperate in tl1e current investigation by calling the Board's office and arranging to be interviewed by the Boaid's investigator and by submitting a written response to this notice and order within fifteen (15) days of the receipt of this letter.

Sirterelv, /\ \\

A II/)...·

.~._v c::-=-r 6 );;,!', 'AI C... I.¥ I ",II

J

"Y. I

"

1 •

d. ..dd..'Lt

Its

Deputy Operations Officer

THE NORTH CAROLINA STATE BOARD OF DENTAL EXAM!NERS

cc:

Case Officer Ms. Carolin Bakeweli, Board Attorney Mi. Frank Recker. Attorney at Law

NcaOARD190

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(

ADDENDU-M TO {NVESTIGATrVE MEMO To;

D!"~ w~ St!!! Hardesty, Case Officer M=. CaroHn Bakewell, Bc:.--d Coun:e!

From:

Line Dempsey, investigator

Date;

August 7, 2007

Re;

SheShe Studio Spa - D!U!J!, (C!!Ie 07"()26)

Initial Complaiot On Februarv 15.2007. I received an anonvmous telenhone call from an individual who wmted at II d~tai offi~ lind hAll seen II flyer for teeth whit~ing. She questioned lite pro"-edure, so she called the ~wod office to ask abol..'t the re~J.!ation of 91.Jch o-yer.Jions. Aecu--rul.ni to the caller, the JI,ice for the system is $139.00 and includes illIprcssions. Company Information SheShe Stut!io SPII Margie Hughes 17336 US 421 Sou."th Dunn, NC 28334 910-890-2681

I did a quick Internet search and found an additional address for SheShe Skin. It had the exact same telephone number. The address was: 206 North Ellis Avenue, Dunn, NC 28334. CorrespondeiiCe

On February 23, 2007, a Cease and Desist letter was sent to Ms. Hughes. Ms. Hughes responded to the letter on March 3, 2007, stating that she had spent considerable time researching into the field and that she failed to see that she was violating any provi-Sion of the !>entJ.l !'rR"lic~ Act. Ms. CILro!in BAl
Stan, thank you b'taldng rnv can. As I noted, there ill a kk!sk perfooring Ight~!!d b!eech!ng on !hI!! e!'!d pe1fents located 1m the ground ftoor of South Pointe Mal In front of Macy". My aoo Gavin lin!!: _ made me aware of It, 80 I went to take a look for myself, The lady with whom I spoke Ie named Ha!!thl!!' York. She said thlltltwaa legal since Itwaa a cosmetic procedure, She said they U88 44% Clllbamde peroxide a:iminlatered a 'gel tray'll They charge $1001 The company she Is aeocIated with Is ih_owsmiie.com

It... ;

Thanks for IoGldi.y lnto am iUipfi$ed that you said ihia has been an ongoing problem I appreciate your :v.a.nd!rtg Soard Irr,;6iitlgr..oi today, and hope you ¢lin get an injunciion 88 you noted is posajbie. Thanks for e! you de for us,

=

H....kt H.rakt O. Heymann, DOS, MEd Profesaor and Graduate Program DIrector Department of Operative Dentistry School of 0enhIry . Univenlty of NOIIh CaroIna Chapa; Hii, He 27589-7450

\-.-1 FAX (919) 988-SGOO

... _1

1ft.. """"

I"'.

_ _ ...

.oo-~I tU

11120/2007 NCBOARD192

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Bobby White From:

Dr Ron owens (drrlcowens®hotmaU.com]

Sent:

Monday, March 17, 2008 8:51 PM

To:

Cc: Subject:

[email protected]; Dr. Joseph S. Burnham; Dr. Stan Hardesty Caroiin Bakeweii; Terry Friddie Re: Team Whitening

Tha.nks, FKO

On 3/17/08 11:22 AM, "Bobby White" wrote: > We're getting lots of calls as a result of the N & 0 article on Saturday. > The reporter has called and i told her that the Board~s ~strategy= was to > continua to look at each kiosk en a case-by- case basis. I also agreed to > eend her a copy of the cease and desist letter we've eent and the > complaint$ in the two lawsuits we have filed~ > > We have also gotten a number of inquiries from people who own or are > contemplating owning one of these outfits. I suggest we draft a brief > statement for your approval so we can say the same thing to everyone. I > should have someehing to you this afternoone

:> > > >

bd~

1 NCBOAR01179

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NORTH C};r. .•~.OLINA STATE BOARD OF DENTAL EXAl'vmrERS JO:i--Vii S. BURNifAM. D.D.B.. PreIidf:rIl W. S1'AN ILUtDii:S"ri. D'&.s., Scc:macy.Trcuu.rct' STANLEY L hLLEt.a, 0.0.8" Piiit~iidwt

CLIFFORD O. FEINGOLD. D.D.s. RONALD K. OWENS, D.D.S. e, WA,YNJ: HOLLAND.D.D.S. Ft"EPLliS S. B...U.L.. R..Jj,H.

ZANNn: P. EFIRD, COOll!-~ M
\ r..

' J....J,.)-W.~

~W.F~Je

Deputy Operations Officer THE NORTH CAROLINA STATE

BOARD OF DENTAL EXAMiNERS

cc:

Case Officer Ms. Carotin Bakewell, Board Attorney

NCBOARD229

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NORTH CAROLINA STATE BOARD OF DENTAL EXAMINERS CLIFFORD O. FEINGOLD, D.D.s. e. WAYNE HOLLAND, D.D.S. BRAD C. MORGAN, D.D.s. NEPLUS S. HALL, R.D.H.

W. STAN HARDISTY, D.D.8., Prcaident RONALD K. OWENS, D.D.B., Sem:tuy-TmIuret JOSEPH S. BURNHAM, D.D.s., Put Preaident ZANNIE P. EFIRD, Coosumtz Membor BOBBY D. WHITE, Chief Operations OffIcer

July 17, 2008

fa v

~! FJun i . C~ ;. Tf ~ l

"J

I

·' , , II

L i4 iin

Ii

Bailey's Ughtning Whitening 320-A Elm Street Greensboro, North Carolina 27401

NOTICE AND ORDER TO CEASE AND DESIST Dear Bailey's: The North Carolina State Board of Dental Examiners is investigating a report that you are engaged in the unlicensed practice of dentistry. Practicing dentistry without a license in North Carolina is a crime. See (NC General Statutes § 90-40 and §90-40.1). You are hereby ordered to CEASE AND DESIST any and all activity constituting the practice of dentistry or dental hygiene as defined by North Carolina General Statutes §90-29 and §90-233 and the Dental Board Rules promulgated thereunder. Specifically, G.S. 90-29(b) states that .... "A person shall be deemed to be practicing dentistry in this State who does, undertakes or attempts to do, or claims the ability to do anyone or more of the following acts or things which, for the purposes of this Article, constitute the practice of dentistry:"(2)

Removes stains, accretions or deposits from the human teeth;"

"(7)

Takes or makes an impression of the human teeth, gums or jaws;N

"(10) Perfonns or engages in any of the clinical practices included in the curricula of recognized dental schools or colleges."

5#1 AIRPOIIT BOULEVA'RD, SUITE lOS' MORRISVILLE, NORTH CAROLINA 17560-8100 TKLBPHON& (919) 6711-8l23 • FAX (919) 678-U71 • EMAIL: [email protected];dCltalbglnl.grK • M\'WoIcdeJItalboard.or&

NCBOARD2887

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Bailey's Lightning Whitening July 17, 2008 Page Two

The North Carolina State Board of Dental Examiners is the state agency charged with regulating the practice of dentistry in North Carolina and is the proper agency to conduct this investigation. The Board may use any legal means at its disposal to conduct this investigation including, but not limited to, interviews with current and former patients, surveillance, and the hiring of undercover agents. The Board requests that you cooperate in the current investigation by submitting a written response to this notice and order within fifteen (15) days of the receipt of this letter. Sincerely,

Gasie S. Goode Assistant Director of Investigations THE NORTH CAROLINA STATE BOARD OF DENTAL EXAMINERS

cc:

Case Officer Ms. Garolin Bakewell, Board Attorney

NCBOARD2888

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CX0388-001

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CX0388-002

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NORTH CAROLINA STATE BOARD OF DENTAL EXAMINERS RONALD K. OWL"'fS, D.noS.. ~t c. WAVNJi: IlOLf.ANJ)~ D,O,s,. Set.:ret!!.!'Y~'fre!!tJrer W, 'iTAN HARDESTY. D,D.s....., Pn:.idcnt

JOSEPH S, BURNHAM, D,D.s. BRAD c. MORGAN, D.D.s. MILLARD w. ""'ESTER. iiI, D.0.8,

7.ANNIE P. EFIRD, COllfilmer Member

QUVD'D.I '0.... r. .... II ........ -.,..n .......... ..'""'...... ""-&.'.["J.

rvNNTPllD &

~~

ft.U,

~

BOBBY D. WHITE, Chief 0p.""iOl18 Offi.,...

September 24, 2008 f'l0 I'

I

i

'

fi --

~,; "'" i

110:

r ~

CERTIFIED MAJURE TURN RECEIPT Triad Body Secrets 1403·8 Hwy 66 S K'g,rna:.r"Cnnllo. I\.fnr+h ~""""""""."''''''I ........ 1011



r"~rn.""_

_!;IIIVII,leI

1)"71')0.04 ,'4u--t

NOliCE AND ORDER TO CEASE AND DESIST To Whom It May Concern: The North Carolina State Beard af Dental Examinais is InvestIgating a report that you are engaged In the unlicensed piactlce of dentistry. Practicing dentistry without a license in North CaiOlina Is a crime. See (NC Generai Statutes § 90-40 and §90-40.1). You are hereby ordered to CEASE AND DESIST any and all activity constituting the practice of dentistry or dental hygiene as defined by North Caronna Genera! Statutes §90-29 and §90-233 and the Dental Board Rules promulgated thereunder. Specific.ally. G.B. 9Q...29(b) states that .... "A parson shaU be deemed to be practicing dentistry in ta,!s State ' 'v-no does, undertakes or attempts io do, or ciaims the ability to do anyone Oi mOie of the foiiowlng acts or things which, for the purposes of this Article, c-onstltute the practice of dentistry:" "(2)

Removes stains, accretions or deposits from the human teeth."

"(7\ ,. ,

T"'kA~

nl"

m~Ii.oQ!:In Im"'l".l~~U,!..... I ..... r'I.""~

• _. _ ................. , ........... ,. III ~1~.,;:J..-:JIVll VI

......... __ ,, __ ,.,og I'UlllC:lIl U:;It:JI,.II, YUill::; ur JaWS,

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"(10) PeifoimS Of engages in any of ihe clinicai practices included In the curricuia of recognized dental schools or colleges."

S!')' AUt.uoaT BCL'......RYAilD.:iu'1TE iU5" MORRiSViLLE, NORTli CAROLINA l1S6Q..8I()(] TiLEPl[ON£ (,}19) 678-8113 • FAX (919) 67S-847l • EMAIL: lJdotii'mcdf'lItalb..rd_ ...•... www.!!d~!!.!!!lb!!!!rd,~~i.

NCBOARD2900

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(

(

September 24, 2008 Page Two

The North Caroiina State Board of Dentai Examiners is the state agency charged with regulating the practice of dentistry In North Carolina and is the proper agency to conduct this Investigation. The Board may use any legal means at Its disposal to conduct this investigation including, but not limited to, Interviews with currant and former patients, surveillance, and the hiring of undercover agents.

The Board requests t"st you cooperate In the currant inv6stigatlon by calling the Board's offics and arranging to be Interviewed by the Board's jnvestigator and by submitting a written response to ihis notice and order within fifteen (15) days of the receipt of this ieiter.

Sincerely, r-00""1",,,

c

_,"",.07lv V.

~,...,..,4,...

~V\,l\.ol1tJ

Assistant Director of investigations THE NORTH CAROLINA STATE BOARD OF DENTAL EXAMINERS

cc:

Case Officer Ms. Carolln Bakawell, 808id Attorney

NCBOARD2901

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NORTH CAROLINA STATE BOARD OF DENTAL EXA.MINERS JOSEPH S. Bt:R:-IHA~I, D.D.S. BRAD C. MORGAN, D.D.S. ~IlLLARD W. WESTER, !II, D.D.S. JE:-INIFER A. SHEPPARD, RD.H.

RONALD K. OWENS. D.D,S .• Presldent C. WAY;\fE HOLLAND, D.D,S., Secretary* lreasurer W. STAN HARDESTi, D.D.S•• Past President Z.-\Nl"·HIi: p, £FIRD, Consumer Member BOBBY D. WHITE, Chief Operations Offkef

November 12, 2008

f'rp [PH

:.)UI r lUC

CERTiFiED MAiURETURN RECEIPT Whitening on Wheels ~v1r. Nathaniel Vinke 1 7111 Kenton Drive Suite 100B Cornelius, North Carolina 28031

NOTiCE AND ORDER TO CEASE AND DESIST Dear Mr. Vinke: The North Carolina State 80aid of Dental Examiners is investigating a report that you aie engaged in Ihe uniicensed practice of dentistry. Practicing dentistry without a iicense in North Carolina is a crime. See (NC General Statutes § 90-40 and §90-40.1). You are hereby ordered to CEASE AND DESIST any and all activity constituting the practice of dentistrf or dental hygiene as defined by North Carolina Generai Statutes §90-29 and §90-233 and the Deniai Board Ruies promulgated thereunder. Specifically, G.S. 90-29(b) states that ... ."A person shall be deemed to be practicing dentistry in this State who does, undertakes or attempts to dc, or claims the ability to do anyone or more of the follo~\o;ng acts Oi things which, for the purposes of this Article, constitute the practice of dentistry:'" "(2)

Removes stains, accretions or deposits from the human teeth;"

"(7)

Takes or makes an impression of the hUinan teeth, gurns or jaws;"

-(1 U) Performs or engages in any of the clinical practices included in the curricula of recognized dental schools or colleges."

501 AIRPORT BO(;lEYARD, SllITE HIS· "IORRJSVU.U:, "ORTH C-\ROU1\A 27560-821)1) TELEPHO"E (91
O ........ L'l T .. ,,,, I

a~l;J

['ITI" .. r Ii. I

'.; U ii I I U Ll'jl U"\L

I YYU

The North Carolina State Beard of Dental Examinsis is the state agency charged with regulating the practice of dentistry in Norih Caroiina and is the proper agency to conduct this investigation. The Board may use any legal means at its disposal to conduct this investigation including, but not limited to, interviews with current and former patients, surveillance, and the hiring of undercover agents.

The Soard requests that you cooperate in the current investigation by submitting a written response to this notice and order within fifteen (15) days of the receipt of this jetter.

Casie S. Goode Assistant Director of Investigations THE NORTH CAROLiNA STATE BOARD OF DENTAL EXAMINERS

cc:

Case Officer Ms. Carojin Bakewell, Board Attorney

5U7 AIRPORT BOULEVARD, SCTTE 105' .\-IORRISVILLE, "IIORTH CAROLI:'oiA 1.,560-8200 TELEPHONE (91(}) 6iS-822J· F,\X (9i9) 678-847t· £;\"IAIL: In:.fu.!:itncdeJItalhoard Dr'" www.ncdcntalboard.org

NCBOARD1903

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ADA American Dental Association" America's leading advocate for oral health

Tooth WhiteninglBleaching: Treatment Considerations for Dentists and Their Patients ADA Council on Scientific Affairs September 2009

©2009 American Dental Association. All rights reserved.

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Tooth Whiteni ng/Bleachi ng: Treatment Considerations for Dentists and Their Patients ADA Council on ScientificAffairs Introduction Over the past two decades, tooth whitening or bleaching has become one of the most popular esthetic dental treatments. Since the 1800s, the initial focus of dentists in this area was on in-office bleaching of non-vital teeth that had discolored as a result of trauma to the tooth or from endodontic treatment. By the late 1980s, the field of tooth whitening dramatically changed with the development of dentist-prescribed, homeapplied bleaching (tray bleaching) and other products and techniques for vital tooth bleaching that could be applied both in the dental office and at home. The tooth whitening market has developed into four categories: professionally applied (in the dental office); dentist-prescribed/dispensed (patient home-use); consumerpurchased/over-the-counter (OTC) (applied by patients); and other non-dental options (e.g., mall kiosks, spa settings, cruise ships). Additionally, dentist-dispensed bleaching materials are sometimes used at home after dental office bleaching to maintain or improve whitening results. Consumer whitening products available today for home use include gels, rinses, chewing gums, toothpastes, paint- 'on films and strips. The latest tooth whitening trend is the availability of whitening treatments or kits in non-dental retail settings, such as mall kiosks, salons, spas and, more recently, aboard passenger cruise ships. Nondental whitening venues have come under scrutiny in several states and jurisdictions, resulting in actions to reserve the delivery of this service to dentists or appropriately supervised allied dental personnel. Current tooth bleaching materials are based primarily on either hydrogen peroxide (H2 02 ) or carbamide peroxide. Both may change the inherent color of the teeth, but have different considerations for safety and efficacy. In general, most in-office and dentist-prescribed, at-home bleaching techniques have been shown to be effective, although results may vary depending on such factors as type of stain, age of patient, concentration of the active agent, and treatment time and frequency. However, concerns have remained about the long-term safety of unsupervised bleaching procedures, due to abuse and possible undiagnosed oral health problems (from P&G comment #2). Although published studies tend to suggest that bleaching is a relatively safe procedure, investigators continue to report adverse effects on hard tissue, soft tissue, and restorative materials.i13 The rate of adverse events from use or abuse of home-use OTC products is also unclear because consumers rarely report problems through the FDA Medwatch system. Based on these factors, the ADA has advised patients to consult with their dentists to determine the most appropriate whitening treatment, ©2009 American Dental Association. All rights reserved.

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particularly for those with tooth sensitivity, dental restorations, extremely dark stains, and single dark teeth .4 Additionally, a patient's tooth discoloration may be caused by a specific problem that either will not be affected by whitening agents and/or may be a sign of disease or pathology that requires dental therapy. The purpose of this report is to outline treatment considerations for dentists and their patients prior to tooth whitening/bleaching procedures so that the potential for adverse effects can be minimized. This report does not address agents used for non-vital intracoronal bleaching procedures. Safety Concerns with Tooth Bleaching Materials long Concerns regarding the safety of all bleaching treatments and products have 5 -8 bleaching. at-home existed, but were heightened since the introduction of Discussions in this section focus on peroxides and their use as active ingredients in tooth bleaching materials. Important concerns related to patient examination and diagnoses are addressed elsewhere in this report. A variety of peroxide compounds, including carbamide peroxide, H2 0 2 , sodium perborate and calcium peroxide, have been used as active ingredients for bleaching materials; however, essentially all extracoronal bleaching materials currently available for whitening of vital teeth in the United States contain carbamide peroxide and/or H2 0 2. Recently, products containing chlorine dioxide were introduced in the United Kingdom, but there is no evidence that tooth bleaching products using chlorine dioxide as the active ingredient are safer than peroxide-based materials. In fact, safety concerns have been documented with chlorine dioxide and its use for9 tooth bleaching treatment due to the low pH of the material and resultant tooth etching. Most OTC bleaching products are H20 2-based, although some contain carbamide peroxide. Carbamide peroxide decomposes to release H2 0 2 in an aqueous medium: ten percent carbamide peroxide yields roughly 3.5% H2 0 2. In-office bleaching materials

contain high

H2 0 2

concentrations (typically 15-38%), while the

H2 0 2

content in at-home

bleaching products usually ranges from 3%to 10%; however, there have been homeuse products containing up to 15% H2 0 2 . (from consultant #6 comment 12 and P&G comment #3)

Safety issues have been raised regarding the effects of bleaching on the tooth structure, pulp tissues, and the mucosal tissues of the mouth, as well as systemic ingestion. Regarding mucosal tissues, safety concerns relate to the potential toxicological effects of free radicals produced by the peroxides used in bleaching products. Free radicals are known to be capable of reacting with proteins, lipids and nucleic acids, causing cellular damage. Because of the potential of H2 0 2 to interact with DNA, concerns with carcinogenicity and co-carcinogenicity of H2 0 2 have been raised, although these '1 1 However, studies (added references from consultant #3 point 1) have shown that H2 0 2 is an irritant and also cytotoxic. It is known that at concentrations of 10% H 2 0 2 or higher, the chemical is 5 concerns so far have not been substantiated through research .

potentially corrosive to mucous membranes or skin, and may cause a burning sensation @ 2009 American Dental Association. All rights reserved.

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SCOP, in January 2008, again recommended that up to 6% H 20 2 is a safe limit to use for at-home tooth bleaching; however, it did not recommend use of such products without dental consultation.2

In summary, available data indicate that extracoronal bleaching treatment in the dental office or at home may cause short-term tooth sensitivity and/or gingival irritation. More severe mucosal damage is possible with high H2 0 2 concentrations. While available evidence supports the safety of using bleaching materials of 10% carbamide peroxide (3.5% H2 0 2 ) by dental professionals, there are concerns with the use of at-home bleaching materials with high H2 0 2 concentrations. Studies designed specifically to assess the long-term safety of high H 2 0 2 concentration in at-home bleaching materials are needed, especially for repeated use of these products. There appears to be insufficient evidence to support unsupervised use of peroxide-based bleaching materials. Similar to other dental and medical interventions, questions have been raised about the safety of tooth whitening treatments during pregnancy. In the absence of such evidence, clinicians may consider recommending that tooth whitening be deferred during pregnancy. The safety of tooth bleaching for children and adolescents is also a consideration. More research is needed to establish appropriate use and limitations for these patients. However, bleaching is a conservative approach compared with restorative options when tooth discoloration causes significant concern. If possible, delaying treatment until after permanent teeth have erupted is recommended, as is use of a custom-fabricated 2 bleaching tray to limit the amount of bleaching gel. Close professional and parental/guardian supervision are needed to maximize benefits and minimize adverse effects and overuse. Bleaching Treatment Considerations General Considerations A typical dental examination begins with a health and dental history. Intra-oral and extra-oral examinations of the hard and soft tissues of the mouth and head are also conducted to exclude or diagnose cancer, abscesses, periodontal disease and other pathology. Seminal to decisions regarding tooth bleaching, the patient history would include the patient's opinions regarding the cause of tooth discoloration, a history of allergies (which may include ingredients in bleaching materials), and information regarding any past problems with tooth sensitivity. Some tooth discolorations may be the result of pathology or conditions that require endodontic therapy, restorations or dental surgery. Such diagnoses can only be made by a dentist or another licensed health care professional, depending on local licensing regulations. In light of these and additional factors noted below, a dental examination with appropriate radiographs or other screening or diagnostic tests is recommended prior to considering tooth bleaching.

@2009 American Dental Association. All rights reserved.

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supervised (consultant #3 point 5) nightly treatment. Diagnosis of the cause(s) of tooth discoloration followed by an explanation of the projected treatment time, benefits and risks are important considerations to address patient concerns and set reasonable expectations. (P&G comment #14). Bleaching products should ideally be formulated at neutral pH. Carbamide peroxide seems to be more effective overnight as a result of its urea content elevating the pH to desirable levels. Hydrogen peroxide formulations are short-acting and have a lower pH. Overall, there does not appear to be any clinical advantage to using equivalent 2 concentrations of hydrogen peroxide or carbamide peroxide in tooth bleaching. 2 consultant #6 point 15) The choice between the two types of products relate to the patient's lifestyle, caries history, tooth sensitivity, and discoloration type. The need for widely, from as soon as 1 to 3 years after initial treatment to re-treatment also varies 29,3 more than 10 years. With in-office bleaching, both proper isolation and protection of mucosal tissues are essential. Dentists may also wish to consider prescribing non-steroidal anti31 inflammatory medications prior to treatment' since post-treatment sensitivity is unpredictable. The treatment schedule may also be a useful method to help minimize tooth sensitivity. Multiple appointments are typically scheduled 1 week apart to allow sensitivity to abate. A "bleaching light" is sometimes used with in-office bleaching procedures as well. Some reports suggest that pulpal temperature can increase with some bleaching light use, depending on the light source and exposure time. Use of 32 . limits safety lights may result in exposure levels approaching or exceeding use of (consultant #6 point 16) Pulpal irritation and tooth sensitivity may be higher with 33 3 use. their with advised been has caution and application, heat bleaching lights or There is conflicting evidence on the effects of bleaching lights on tooth color change. Most studies comparing effectiveness of in-office bleaching with or without light application were conducted in vitro. 3 The effects on tooth color change were variable, and some differences detected electronically were not detectable3 visually. This observation was reported in a recent clinical study report as well. Of studies 3 3 Heat conducted in vivo, most found no added benefit for light-activated systems. and light application may initially increase whitening due to greater dehydration, which reverses with time. Actual color change will not be evident until 2 to 6 weeks after bleaching treatment. 3 The average number of in-office visits for maximum whitening is three, with a range of or for a 1 to 6 visits, so the patient should be prepared for additional in-office 3treatments 8

combination of office visits and tray delivery to complete the

process.

As noted previously, the unsupervised use of OTC whitening products raises concerns about possible masking of undiagnosed pathology (whether related to tooth discoloration or not), cosmetic or functional aspects of existing dental restorations, and unknown allergies or other untoward responses. In addition to these safety concerns, absent a dental examination and consultation, user expectations may not be realistic. @ 2009 American Dental Association. All rights reserved.

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American Academy of Cosmetic Dentistry - 06_27 Introducing the White ...

http://www.aacd.com/index.php?module=cms&page=55

Find a Cosmetic Dentist Join AACD • Find a Laboratory Technician |

Press Releases FOR IMMEDIATE RELEASE Contact: Eric Nelson American Academy of Cosmetic Dentistry ® 5401 World Dairy Drive Madison, WI 53718 PH: 608.222.8583 Fax: 608.222.9540 E-mail: [email protected] Web: www.aacd.com First it was Atkins, then it was South Beach, now it’s the White Smile Diet June 22, 2006 - Madison, WI - The most unattractive thing about a smile are discolored teeth, according to a recent American Academy of Cosmetic Dentistry (AACD) consumer poll. And the numbers prove it! Whitening treatments are the number one requested cosmetic dental procedure and have increased more than 300% since 1996, according to the AACD. “While daily home care and regular professional cleanings are essential for maintaining healthy teeth and gums, certain foods can help remove stains from your teeth,” said AACD President Dr. Marty Zase. “Foods such as apples, pears, celery, carrots, cauliflower, and cucumbers produce saliva which combines with the foods’ natural fibers to naturally clean teeth and remove bacteria.”

White Smile Diet Foods and Tips include: Strawberries will naturally whiten your teeth. Avoid drinking coffee, dark syrup sodas, red wine and blueberries. All stain teeth quickly. Drink from a straw whenever possible…allows food dyes to bypass teeth altogether.

Baking soda will help remove stains and build up. Brush it on your teeth twice a month, just as you would toothpaste, and rinse.

Raw veggies are not only healthy to eat, but they will clean your teeth and remove surface stains.

The mechanical action of chewing sugarless gum can also stimulate saliva and clean teeth surfaces, though not recommended for patients with TMJ.

Locate an AACD Member Cosmetic Dentist The AACD is the world’s largest cosmetic dental organization dedicated to advancing excellence in the art and science of cosmetic dentistry. As with any dental procedure, the AACD recommends consumers consult with their dentist before undergoing any cosmetic dental treatment. The public can locate an AACD member cosmetic dentist via AACD’s free consumer referral system at www.aacd.com or by calling toll-free: ( 800) 543-9220.

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ing company lhal same month (Haywood, 1991a; Goldstein. 1989). For the first time, this technique offered the possibility of whiter viral teeth to a wider section of the general patient population at a much lower cost, with much less danger or side effects, than any of the previous options. Since that time, numerous other products and techniques making claims for bleaching teeth have been introduced (Haywood, 1991a: Albers, 1991). These options include variations on the dentist-prescribed/home-applied techniques. as well as "bleaching kits" sold directly to consumers in stores for unsupervised home use. The nightguard vital bleaching techniques and the OTC bleaching kits have kindled a resurgence of interest in [Ooth bleaching. and have reopened the questions asked 100 years ago: Does it work. is it safe, what are the indications, and how long does it last?

CURRENT SAFETY Nonvital Bleaching The walking bleach technique is probably the most popular option for bleaching nonvital teeth, and no major problems of safety were initially observed other than those associated with the handling of the material and the potential for bums from the high concentration of hydrogen peroxide. This technique involves sealing a mixture of 30% hydrogen peroxide and sodium perborate in the pulp chamber, and changing the solution every 2 to 7 days. The inoffice alternative for bleaching nonvital teeth involves usually a single appointment in which 30% hydrogen peroxide is activated by a heating instrument. which is more efficient. However, later in the I 970s. external resorption was noted in the cervical areas of nonvital bleached teeth (Harrington and Natkin. 1979; Lado et aI., 1983). Early reports linked this with over-zealous use of heating instruments. or with previous trauma to the tooth (Montgomery, 1984; Goon et aI., 1986). Onset was one to seven years post-treatment. and often the tooth was lost. Although the etiology is still unknown. later reports have questioned the heat and trauma theories, and proposed that the resorption may result from exit of the peroxide through the tooth where the enamel and cementum do not join (Lado, 1988). Approximately 10% ofteeth do not have an intact CEl. This theory, along with the observation that pressure in the chamber often causes transient pain, reaffinn that a base material should be placed, prior to inserting the peroxide, over the exposed endodontic filler and over areas which might communicate with the CEl. However, placement of this base often means that a pooion of the tooth that is discolored will have to be masked with the base material, and possibly will not lighten. A significant drop in pH has been observed in the cervical area of the tooth from passage of the peroxide through the tooth and its exit at the CEl (Lado, 1988). Later observations have indicated that the resorption was not actual! y at the CEJ, but more apical (Friedman et a!., 1988). This observation. along with experience gained using calcium hydroxide in the treatment of resorption and incomplete root formation, has led to the practice of filling the pulp chamber with calcium hydroxide powder after the completion of the bleaching to alter the pH and halt the potential osteoclastic activity (Lado. 1988). More recent reports have recognized the greater potential for cervical resorption from the combination of heat and 30% hydrogen peroxide over either treatment alone (Madison and Walton, 1990). For :hese reasons. the safer non vital bleaching technique appears to be the walking bleaching technique, rather than the in~office technique using a heating instrument.

Another approach to treatment involves using sodium perborate alone, rather than in conjunction with hydrogen peroxide, as the primary bleaching agent (Holmstrup et al.. 1988). Although this may be a slower process. it is potentially less destructive to the tooth and hence safer (Warren et aI., 1990). It is unclear why these resorption problems should appear so late in the history of nonvital bleaching. but their recent appearance raises the possibility that changes in materials for endodontic fillers, sealers, or bleaching. or a wide variation by practitioners in administration of the technique, may be the cause. At this time. the wa.lkirIg bleaching technique seems reasonably safe, with- only a slight chance of cervical resorption. The benefit of treatment is relatively great (considering the cost of a crown or veneer, the preservation of remaining tooth structure, the potential for an esthetic outcome, the avoidance of a subsequent weakening of the tooth and the finite life of the other restorative possibilities). and the risk is small. Precautions include sealing the root-filled portion pre-operatively with a material such as polycarboxylate cement, placing calcium hydroxide powder in the chamber post-operatively for 14 days, and following the patient for a number of years with frequent recall radiographs. If there is any evidence of resorption. it may be arrested with calcium hydroxide treatment. and the tooth can be crowned (with or without extrusion of the tooth to manage the defect) (Latcham, 1986).

Vital Bleaching For any vital bleaching~procedure, patients are classified by whether they have tetracycline-stained teeth. or teeth stained from other reasons. Tetracycline-stained teeth are the least responsive to bleaching. depending on the severity of the stain (Jordan and Boksman, (984). With external bleaching, the tetracycline-stained teeth generally get lighter, but not whiter. Some clinicians have recently advocated intentional endodontic therapy on those teeth, with the use of the walking bleach, to overcome this problem (AbouRuss. (982). While the esthetic result appears much better than external bLeaching. this approach raises questions about the success of the endodontic therapy over time. the longevity of the walking bleaching technique, and the potential of the treatment or'retrealment to cause cervical resorption. The most popular technique for the in-office bleaching of vital teeth involves 35% hydrogen peroxide, etching the teeth with phosphoric acid to facilitate bleaching, and either a heating element or a light source to enhance the action of the peroxide (Feinman et a1.. 1987; Goldstein, 1987). Because this technique must be accomplished without anesthesia to allow the patient'S pain threshold to determine the appropriate heat level, there have been numerous studies on the effects ofboch the heat and the concentrated hydrogen peroxide on the pulp (Zach and Cohen, 1965; Nyborg and Brannstrom. 1968). In spite of the fact that there is insult to the tissue, most of the research has shown thatthe pulp remains healthy, and the insult is reversible in approximately 2 months (Cohen, 1979; Seale et a1.. 1981). The observations of many clinicians who have performed this procedure over many years attest to the fact that there have been no pulpal deaths associated with vital bleaching (Feinman et aI., 1987). Research in this area has shown how easily the hydrogen peroxide, because of its low molecular weight. passes through the enamel and demin to the pulp (Bowles and Ugwuneri. 1987). More current clinical studies have eliminated the etching with

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, ' phosphoric acid (Hall. 1991). and the most recent products on the market advocate no use of heat or light for the reaction (Haywood. 1991 a). There have been a number of studies evaluating the effect of bleaching with this high concentration on dentin and enamel, with some hints of structural changes in tetracycline-stained teeth (Ledoux et al.. 1985). However, the most important obseryation has been the decrease in bond strengths of composite [0 bleached. etched enamel immediately afterthe bleaching process (Titley et al.. 1988). Later studies in this area have attributed the decrease to residual perox ide left immediate Iy in the tooth or on the surface (Torneck et aI.,1990). The main safety advantages of the in-office vital bleaching technique are that, although it uses caustic chemicals, it is totally under the dentist's control. the soft tissue is generally protected from the process, and it has the potential for bleaching quickly in situations in which it is effective. Disadvantages primarily are the cost, the unpredictable nature of the result, and the unknown duration of the . treatment. The unsafe features include the potential for soft tissue damage to patient and provider, the discomfort of rubber dam, the temperature on the pulp, and the resultant post-treatment sensitivity. Although early concerns of pulpal response were identified, subsequent research seems to have shown that although this high concentration of. hydrogen peroxide causes changes, they are reversible (Haywood and Heymann. 199]). If etching is perlonned. polishing is required after each visit. with some enamel loss. It is well accepted that this technique works. but the patient must be counseled that, although the result may be permanent. the process more likely will have a 1)03 year duration, at which time the treatment will need to be redone. Also, it cannot be determined prior to treatment whether the teeth will respond, and treatment may take as many as four to six treatments. The labor-intensive nature of the treatment, which in turn requires a higher fee. coupled with the discomfort and uncertainty to the patient, keep this method ofbleaching from being a treatment that is widely accepted. although it can be successfuL Recent innovations for in-office bleaching include chairsidemixed gels, some of which are activated by composite curing lights (Hi Lite Dual Activated Bleaching System, Shofu Dental Corp). According to the manufacturer, this light-activated material changes color when the bleaching pr9cess is complete, which should take only 3 112 minutes. Chemical composition and effects on tooth structure of this technique are unknown as of this date. Other gel fonns do not use heat or light (Starbrite, Healthco). Although they require approximately the same treatment time as the conventional Superoxo] bleaching te~nique. the gels are much easier to manage clinically.

Nightguard Vital Bleaching or Dentist-Prescribed Home Applied Bleaching The most recent vital bleaching technique introduced. originally called nightguard vital bleaching (NGYB) (Haywood and Heymann. 1989) but also referred to as home bleaching or dentist-monitored bleaching. has created a resurgence in the area of bleaching. primarily because of its relative ease of application. the safety of the materials used, the lower cost, its general availability to all socioeconomic classes of patients, and the high percentage of successful treatments. It may be more appropriately termed a "dentist-prescribedlhome-applied" technique. Since the I 0% carbamide solutio., is equivalent to a 3% hydrogen peroxide solution, this solution

is approximateiy one-tenth the concentration of the solutions used for "power" or in-office bleaching. Results are generally seen in 23 weeks, with the final outcome complete in 5-6 weeks (Haywood, 1990). However. treatment times vary extensively, and much depends on the amount of time per day the patient chooses or is able to apply the technique. Later products have offered solurions of hydrogen peroxide that range from 1'k to 10%. and carbamide peroxide solutions that are either IO'k or 150/c concentration (Haywood, 1991 b). The details of this technique have been reported in many articles (Haywood and Heymann, 1989; Haywood and Drake, 1990~ Haywood, 1989, 1990, 1991a: Albers, 1991; Darnell and Moore. 1990). Numerous articles have attested to the efficacy of the technique, which has been successful in clinical trials for approximately 91 % of persons with materially or genetically discolored teeth. and somewhat less successful in 91 % of persons with tetracycline discolored teeth. Tetracycline-stained teeth generally get lighter, but not whiter. Nightguard vital blea('!ling generally has the same indications and prognosis as the conventional in-office bleaching. but can be accomplished at a much lower cost and with fewer side effects, such as tissue burns and sensitive teeth. A recent survey with 7,617 dentists responding indicated greater than 90% success rate for the technique; 90% of the dentists use a 10% carbamide peroxide (Christensen. 1991). Specific questions as to safety ofNGYB were recently addressed in the article by Haywood and Heymann (1991). The controversial element that the nightguard vital bleaching technique adds to conventional bleaching options is the potential for contact of the soft tissue during treatment and from ingestion of the materiaL This contact sometimes results in one of the two common side effects, an irritation of the gingival tissue. More than half the time, this irritation is related to an ill-fitting prosthesis. Other times, it is the tissue's response to the peroxide. There are numerous reports of the effects of hydrogen peroxide on tissue (Wietzman et a1.. 1986; Donnan and Bishop, 1970; Martin et al., 1968). However, those effects are generated by conditions which exceed greatly the time and dosage of peroxide used in this bleaching technique (Haywood and Heymann. 1991). The previously mentioned survey confinned that one third of patients bleaching their teeth in the home manner did not have side effe~ts, while those that did experienced either transient tooth sensitivity or gingival irritation (Christensen. 1991). The fit of the guard was a major cause of gingival irritation. Reports from industries which make hydrogen peroxide state "it is improbable that humans will be exposed to high oral doses of H 20 2 due to the acute toxicity of concentrated solutions and the corrosivity of H,o., to mucous membranes. An individual would theoretically have to drink daily 23 mt of 35% hydrogen peroxide for a lifetime to develop the lesions seen in mice" (FMC Corp, 1988). Hydrogen peroxide is approved as generally recognized as safe for use as human food additive with no residues. More recent studies directly evaluating the effects of 10% carbamide peroxide on tissues and in animals systemically have indicated that the effects of 10% carbamide peroxide on tissue are less than or equal to many other accepted dental medicaments, such as eugenol (Woolverton et ai., 1986), or other dental procedures (Haywood and Heymann. 1991). The most conclusive evidence to date has been the work of Dr. Chris Woolverton (1991) establishing the non-mutagenic nature of 10% carbamide peroxide, the safe level

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.0n, and the minimal effects on cell lines. Even in tray that seek to avoid covering the attached gingiva, the .~rdental papillae is still exposed to the solution. Hence, the total avoidance of soft tissue contact is impossible as the technique cur· rently stands. Conclusions from evaluations of the other studies indicate that toxicity and mutagenicity of hydrogen peroxide is doserelated (Cantoni et aL. 1986), and the concemrarions used in the home bleaching technique are not of sufficient strength to warrant concern to the soft tissue (Haywood and Heymann, 1991). In fact, although a high, sudden dose of hydrogen peroxide is toxic to cells. a lower dose over a longer time allows cells to adjust and actually ultimately tolerate a higher dose that than which originally would have been toxic (Winguist et at, 1984). Also the long history of clinical usage of the solutions with soft tissue contact ranging from 7 days to three years, in patients ranging from new-born infants to geriatric patients, has demonstrated no problems (Haywood and Heymann, 1991). Vanous effects of the carbamide peroxide on teeth have been studied (Haywood et aI., 1990, 1991; Hunsaker et ai., 1990). Generally, these reports find the effects to be nonexistent or to be no worse than those already found with in-office bleaching. Although there have been varying reports concerning the effect on enamel, there does not seem to be a significant effect on the morphology of the enamel surface outside the normal variation of enamel (Haywood et a1., 1990, 1991 ~ Scherer et aI., 1991). No published reports have demonstrated any change in hardness of enamel, nor have studies at the University of North Caro11na shown any significant concerns (McCracken, 1992). Studies which evaluate change in the surface must take into account the remineralization potential in the mouth, which may negate any potential changes. There has been one observation that toothbrush abrasion was more significant in the presence of bleaching agents (Kalili et aI., 1991), while yet another slightly different study showed brushing with the solutions had no effect (Scherer et al., 1991). Another report has shown the at-home bleaching procedure to be a controlled oxidation process in which the organic phase of the enamel is mobilized wi thout producing gross} y unacceptable enamel surface topography (Covington et al., 1990). Clinically, there is no apparent loss, and the tooth retains it glossy appearance. There have been reports of internal matrix changes from bleaching with 35% hydrogen peroxide after laboratory-induced tetracycline staining (Ledoux, 1985), but there is no direct correlation between this study and the milder hydrogen peroxide, nor have these changes been demonstrated to have any clinical significance. Studies dir~tly on dentin and enamel with 10% carbamide peroxide materials have demonstrated no structural Joss (Covington et al., 1991). The effects on the pulp were extensively evaluated in the previous generation of bleaching with 35% hydrogen peroxide, and the lower concentration of peroxide would not be expected to be as derrimental to the pulp. The effects on pulp have not been directly evaluated with the weaker peroxide solutions, but the research on 35% hydrogen peroxide has shown effects which are reversible over time, with no clinical consequence other than immediate but transient sensitivity. Clinical trials on nightguard vital bleaching techniques in progress at the University of North Carolina have found no predictors of sensitivity relative to patient age, pulp size, presence of exposed dentin or cementum, caries, or leaking restorations. The ]imitation for how young the child is able to be treated is more related to the available numberof pennanent teeth to retain the .tS

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guard and the desire not to impede the eruption of permanent teeth as they attempt to rapidly enter the oral cavity than to pulpal sensitivity. The occasional mild tooth sensitivity associated with nightguard vital bleaching is attributed to the easy passage of the hydrogen peroxide and urea through the enamel and dentin to the puLp and the resulting mild irritation. This ceases upon termination of treatment (Haywood and Heymann. 1991). Because the concentration of hydrogen peroxide is lower. certain patients that could not tolerate the in-office bleaching due to discomfort have found the nightguard vital bleaching technique to be acceptable. Any effects on restorative materials have been limited primarily to composites, both with co [or change and surface integrity O-Iunsaker et aI., 1990). Basically. there is no appreciable change in the color of any restorative material clinically. Although there have been conflicting reports recently in this area as to composites (Friend et al., 1991; Monaghan et al., 1991; Kao et al.. 1991; Tenaglia et al., 1991). the ability of the colorimetl!rs to measure differences is limited. and this color difference has not yet been calibrated to clinically detectable changes. Clinicians must assume there will be no color change in any material (although the stains may be removed from the surface and margins of porous composites. etc.), and patients should be ad vised of the potential need for replacement of any esthetic restorations if the shade of the composite resin is not clinically acceptable postbleaching (Haywood, 1990). Reports of the dissolution of a portion of the matrix have also concluded that it may be clinically inconsequential (Christensen, 1989). Since the composite may have to be replaced afterwards, any loss may be of no significant concern. \Vhetheuhis bleaching technique wilf have a significant effect on the long-tenn wear of posterior composite resins (Bailey and Swift, 1991) is still unknown, because other reports have shown that composite resin hardens after exposure to bleaching solutions (Friend et a1., 1991). Porcelain, amalgam, and gold have not responded with either color change or alteration of structure, so they are considered unchanged by the bleaching process (Hunsaker et aI., 1990). Of current interest to the clinician is the effect of bleaching on bond strength of etched enamel to composite resin. Earlier reports had associated a decrease in bond strength of treated enamel to composite with bleaching using 35% hydrogen peroxide (fitley et a!., 1988). This occurrence has also been con finned with the 3% peroxide (McGuckin et at. 1991). but has been related to the residual oxygen in the tooth, and the bond has been shown to increase, approaching the original strength over time (McGuckin et aJ., 1991; Haywood and Heymann, 1991). More recent studies of the 35% inoffice bleaching techniques have also attributed this loss to residual peroxide temporarily remaining in the looth, or to surface changes (TomecketaL, 1990). Another study of home bleaching techniques demonstrated that roughening the surface slightly also eliminates this phenomenon (Cvitko et a1.. 1991) . Generally, etching and bonding should be delayed at least 14 days aftertermination ofbleach.ing until further studies can determine a more precise waiting time. Safety to the occlusion and the temporomandibular joint during the bleaching process must also be considered. Typically, occlusal problems during NGVB may be either mechanical or physiologic. Mechanicall y, the patien t may occlude only on posterior teeth. rather than on all the teeth simultaneously. Sequentially removing posterior teeth from the guard until all the teeth r.ontact will rectify the problem, and avoid the potential for joint disturbances. Ifthe patient is a bruxer, he or she usually will wear a hole in the appliance over

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me. and another will have to be made. There has been no success ) date in fabricating an occlusal devise for bruxism that can also ;!rve as a well~fitting guard for bleaching. Physiologically. if the ·::ltient has pain in the joint. the posterior teeth can be removed from ~t! guard until only anterior guidance is remaining, and the patient's .::ear time reduced or limited to the day only. Another area of concern with safety is how often the procedure ::; has since been covered by another restoration, such as an etchedmetal resin-bonded fixed partial denture. External bleaching avoids unnecessary removal of an acceptable dental restoration, and the loss of tooth structure during the process which weakens the tooth, and prevents additional insult to the cervical area from another 35% hydrogen peroxid~ treatment. Even after successful treatment with a walking bleach, often the bleached tooth is more yellow than the other teeth. Nightguard vital bleaching then can be used to harmonize the colors of the vital and non-vital teeth. Teeth that are endodontically treated, but have such a thin portion of remaining dentinal at the cervical that there is concern about potential cervical resorption from use of the 35% hydrogen peroxide. are also amenable to the nightguard vital bleaching technique as the first choice of treatment. The nightguard vital bleaching technique should be considered as the first choice for any discolored teeth, even those considered for the placement of porcelain or other esthetic veneers. Attempting nightguard vital bleaching first may avoid the need for veneers. However. even if the technique is unsuccessful in achieving the desired shade. or there are other indications for veneers other than the color, bleaching may lighten the underlying tooth base and make the subsequent veneer more esthetic, as well as a\]ow the patient to evaluate the results of the more conservative option first. Home bleaching can be used prior to single porcelain-fused-to-meta\ or ceramic crowns. fixed partial dentures, or removable partial dentures in order to offer a lighter. younger-looking shade. as well as eliminate some of the difficult crack lines or characterizations that are not easily duplicated in ceramic restorations. Nightguard vital bleaching can minimize the discoloration of the stained incisal edges of lower teeth, and minimize the effects of white spot lesions by lightening ·the tooth structure adjacent to the 'white spot lesion. Not only is nightguard vital bleaching effective as a pre-operative treatment, but it1's also effective post-treatment to lighten natural teeth to match existing ceramic crowns, fixed partial dentures, or Dicorrestorations. This lightening can be achieved to match crowns to adjacent teeth in one arch or to teeth in the opposing arch. Bleaching can also increase the life on three-quarters crown abutments, onlays. or resin bonded fixed partial denture abutments that have darkened more than their originally-matched porcelain pontic. Bleaching has even been successful in increasing the life on previous composite bonding by lightening the underlying tooth structure to compensate for the wear of the composite, or used to lighten the apparent color of veneers already cemented by lightening the underlying tooth slructure. This lightening effect is due to the ability of the carbamide peroxide to freely pass through enamel and dentin and to permeate to all parts of the tooth. even those protected by restorations (Haywood et aI., 1991).

Although the success and acceptance of the nightguard vital bleachi ng technique has been phenomenal, it has not eliminated the in-office bleach ing (Garber et al.. 1991). Some patients' lifestyles do not lend themselves to extended treatment times. or outside-theoffice appliances. Also. they may not be willing to wait the time for home bleaching to be effective. They may not be concerned about the greater financial investment of in-office bleaching. or may not be able to wear the guard and tolerate [he taste of the solutions used in nightguard vital bleaching. rn these situations, in-office bleaching is indicated. It is also indicated if the pa[ient does not respond well to the nightguard vital bleaching regime. In clinical trials at the University of North Carolina, a single in-office treatment delivered after a lack of response to nightguard vital bleaching, following by continuation of the nightguard vital bleaching treatment. has achieved results that neither technique showed independently. In those cases, the teeth were not etched, and neither heat nor light was employed. Other recommendations include beginning bleaching with the inoffice treatment, foHowed by the home II-eatment (Garber et aI., t99t). Other clinical pilot studies also at the University of North Carolina have shown reduction in the build-up of chlorhexidine stains when a 10% carbamide peroxide was used in an alternating fashion wi(h the mouthwash. Other preventive opportunities being explored ha\'e included using the nightguard vital bleaching system to at· tempt to reduce the incidence of root caries that is unresponsive to traditional fluoride and tray systems (Firestone et al.. 1982). This caries is often related to xerostomia and is a sequelae to radiation therapy, chemotherapy. medical problems, or aging (Seals and Dorrough, 1984). There is hope to evaluate the nightguard vital bleaching application in nursing homes or hospitals. where attendants may be able to add this application technique to the oral hygiene regime for patients with inability to perform adequate oral hygiene measures (Shapiro et a1., 1973).

CONCLUSIONS The profession should neither propose a sweeping condemnation nor offer a sweeping endorsement of bleaching any more than it should any other treatment option or medicament used in dentistry. Bleaching techniques that have been shown to be reasonably and relatively safe and effective, both in current usage and over time, should be accepted as a reasonable treatment option (Christensen, 1991; Golub-Evans, 1991). knowing the risks and benefits. Continued research should be undertaken on these and all other dental treatments. These accepted techniques includc nonvital bleaching with 35% hydrogen peroxide andior sodium perborate (but without heat), in-office vital bleaching with 35% hydrogen peroxide (but without etching), and nightguard vital bleaching (dentist-prescribedlhome-applied bleaching) with 10% carbamide peroxide materials or similar products. Conversely, claims that any use of hydrogen peroxide will bleach teeth and all techniques arc safc cannot be accepted blindly. Especially in question are the aTe bleaching kits, and toothpastes containing carbamide peroxide. Effectiveness and safety of the bleaching technique must evaluate not only the product but also the delivery method and treatment time. Unbiased research is still the best avenue for sifting through the claims and reports to a better understanding of what is correct and what is incorrect (Haywood. 1991a). Over time. the understanding of TMJ function has changed radically. the correlation between occlusion and pain has altered. the change from pins to slots in

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nkI [l nnIT! AI b U I~ [ I!J un I ML

(I

Care!!n Bakewell From:

Bobby -rtniie [email protected]

Sent:

Wednesday. February 20. 20084:21 PM

• v.

'Mark essErI

ee:

Carolin Bakewell (E-mail)

..._.

SubJ..::t; RE: OYes!ion

Thanks for you insight and for bringing Dr. King in the ioop. We've used at ieast one of the experts you racommandad In otr.ai ma~L6I-s and may be contactinQ him again depending on how far these iawsuits progreu. !'m for..-vardlng your rs:ponsa to Cardin Bak6"""aU, CUi legal coun~, you may be hearing from her as weli.

Thanks

l

Bobby --original Me=s3ge From: Malit Casey [mallto:[email protected] Sent: Wednesday, February 20, 2008 4:05 PM TO: [email protected] Subject: Re: Question

Bobby: Sec my response to your questions below. Thanks,

M!!...1'k Bobby \Vhite wTOte: Mark: You have discovered one of many such "bieaching kiosks" WIth which we are currenUy going

fOflh to do bliilie. ihis one and several oihers are on ihe proverbial radar screen. WeVe sent out numerous CEiii8e and desist orders throughoui the state and currentiy have iawsuits flied In M-o diffar,;;.. t counties Cepe.,cHng 0.. how u~y go about it, we consider this the un!!cerIsed prac+Jce of dentlst.-I_ The fact that v.~ have had to brtng two lawsuits however, l

indlc-ate! th.at we are dealing with welf-financed ~..:s!ness8S \,\'he \\'Ould raL"ar support litigation than give up on the bleaching business. AJe there other pubUc hea!t." concerns raised by these buslnesses?Yes. , would tl,!nk so. There are severa! unintended side effects that could occur when oatients underaa bleachlna treatmBnl!;~ I think that H is follow-up -Bte;;~hBright or their imperative that patients have somewnere to go competitors have any means to offer post·treatment care if the customer experiences. for example. cervical sensitivity due to the bleaching treatment? In my opinion. unlicensed activity may negatively impact the public welfare if the activity is performed by sameone who can not prOVide comprehensive oral health care services. I guess another point ta consider is ihat unlicensed activity af this nature is not regulated by any state agency with the power ta discipline folks who are negligent in their care of the custamer. What legai recourse wauld a customer of Bieach6fight have against a business entity that provides orai heaith care serY'ices bu1 ieaUy does not answer to any aumomy with knowiedge of orai heaith care? IT SOl do you kr.o-..v of anyone that would be willing to piovkfa a stateineFit to that effect? i guess

fa

Csre.- Daes

2/20/2008 NC80ARD52

1236

CX0404-001

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 224 of 366

U-lSt this issue IS probably not In my purvlew since it does not Involve Medicaid iGCipients. I asked Rebecca King to taka a look at the email discussion to SaG if she had any t."loughts from a dental pubHc health perspactry's. The othar tho-~ght that ! had, that you aU are probably '113, ahead of me on, is t.-'at perhaps 3: dental expert on est"et.ic treatment like Harald Heymann (UNC SOD) or Van Haywood (Med!ea! College of Georgia and used to be on the faculty at UNC SOD· he has published many journal art.Jc!es on bleaching) could weigh In witt, an opinion about whether this unllc.ensed activity is in the best interests of the CL!stomerJpatient Thanlt.s for letting us know about tl1!s and for an tlla! you do to help dentistry in this state. My pleasure and thanks for the compliment Not $yre that I have done much to deserve such high praise, but I hope to prove worthy in the future.

Bobby --Qriginai Message From: Mark Casey [mojito;Mark.i""[email protected]

s.nt: Monday, February 18, 2008 9:02 AM To: BoDby Vihite SUbjKt: Question Bobby: Hope you are doing well.

I was at lunch the other day at Crabtree Valley Mall and noticed that a kiosk

had been set Ltp by II bu.~ines.5 interest \mown as BleachSright http://www.bleachbrifd!,lcorn/. The folks at the two chAit" operation seemed to ~.:s+.omers \vith trays {probably disposable s""wck trays)t a hydrogen Ji'avxide bleaching agent and a bleaching light. I asked a few questions of a gentiem.a:n at the kiosk and it seemed to we that thge was no dentist on site for supervision. From a quick iook at ibeir website, it appears that they are claiming that since the customer inserts the tray themseives that this is acceptable under state dental practice laws.

be providing bleaching tr-,.,atments to

I recall an old Board newsletter that addressed the issue of bleaching treatment and I believe that it advised that bleaching treatments should always be ~t-1n'\1"'otered by a dentist. I know that due to potentia! effect...! on the gingiva leading to cer.ica1 ~ansitivity that app!i=tion by a lice".....Bee is critical. Not S'I.ll"e if you have been advised of this potential unlice-uSed &..-tivit";, but I thought that it bears repeating even if you are aware of the situation. The gentleman ad:vised me that the kiosk is open seven days a week. Tney are iocated near me first level entrance to the mall near Panera Bread on the back side of the mall facing Crabtree Creek.

Thanks, MMk

[J fv1iU....Jj{ W. Casey DDS, ~vfPH Dental Director Division ofMedicai Assistance

NCBOARD53

1237

CX0404-002

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 225 of 366

c0r~ F! 0Un! Al

2501 tvfail S-iIvice Center Raieigh, NC 27699-250i Phone: (919)855-4280 Fax: (919)715-2738 . Mark.CasevCalncmail.net Whenever documents ac.c~pAny1ng ~n e-mR11 contain confidential health informatio~ such documents a..~ legally priv;Jeged. The authori&2ed recipient of such documents is vIo}-,dbited from disclosing this information to any other party uniess required to do SO by law or reguiation. Recipients are required to destroy such iniormation after its stated need has been fulfilled. If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution, or action taken in reliance on the contents of these documents is strictly prohibited. If you have received this information in errur, please notify the sender immediately and delet..e the e-w.ai1 and accompanying file a:t4"..achment.

LJ

Mad: W. Casey DDS, MPH Dental Director Division of Medical Assistance 2501 Moil Servi.c.e Center R.aleigh, NC 27699.,,2501

Phu"'""ne: (919)855-4280 Fax: (919)715...2738 [email protected]

Vrnenever documents accompanying an e-mail contain confidential health information, such documents are legally privileged. The authorized recipient of such documents is prolubited from disclosing this information to any other party Unless required to do so law or regulation. Recipients required to de~troy such info~ation after its st-Rted need hR... been pllfilled. If you !!..Te not the ;ntended recipient, you a..re hereby notified that any discloS".Jre, copying, distn.'bution., or action taken in reliance on the contents of these doc'wucllLs is strictly prohibited. If you have received this infonnatiofi in error, picase notifY me sender immediateiy and deiete me e-mail and accompanying fiie attachment.

bv

are

2/20/2008 NC80ARD54

1238

CX0404-003

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 226 of 366

Bobby D. Whits

Referencing \\fhitening/Bieaching

2004 - 2010 10 Feb 04 2 Dr. Chrisiopher Pheips 704-845-1107 [e-mail: My name is Christopher Phelps. DMD and I am cufrenuy practicing in Charlotte, North Carolina. I have recently discovered a business opportunity that is tied in with Dentistry but i wouid like to speak with an attorney who is familiar with the Laws of NC and the mles governed by the Siate Board of Dentistry. If you could em all me a number where! could reach you or someone who can answer fHy quesiions, i would be very appreciative, My office number is 704·845-1107 and my email address is [email protected] ..net. Thank you for your time,Dr. Phelps] - ? about company called "Bright

smile" all they do is teeth whitening. Wants to knc\"J if it is ok if he worrLI Cain Have a Elri:glhter, Whiter Smile for the Holidays.

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Buena Vista Smiles

Appeal: 12-1172 Pg: 235 of 366

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NCBOARD60B 1

1249

CX0455-002

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 237 of 366

Page 1 of I

Bobby"'''Jhite From:

Ron O.... [email protected]

Sent:

Tuesday, Aprii 06,20105:07 PM

To:

Terry Friddle; Bobby White

Subject: RE: Case Assignment 10-061 Please see if you can find out how they are whitening.

Thanks, RKO

From: [email protected] To: [email protected] Subject: Case Assignment 10-061

Date: Tue, 6 ,lI.,pr 201012:47:52 -0400 Here's another tooth whitening case for you. Shall we send the "approved" cease & desist letter. or do you want us to send someone to check it out?

Terry' VI. Friddle Deputy Operations Officer NC State Board of Dental Examiners 507 Airport Boulevard, Suite 105 Morrisville, NC 27560

(919) 678-8223 Direct DiaL (919) 459-1791

From: [email protected] [maHto: [email protected]]

Sent: Wednesday, March 10, 2010 5:52 PM To: [email protected],org

Subject: From Ross W, Nash, DDS, Chartotte

Terry. J was in South Park Mall in Charlotte earlier this week. They have a kiosk where an individual is performing whitening procedures. it is cailed Pro White. Jennifer Shepard suggested that I infonn you so the Beard can give t1em a cease and desist oider. Thank you.

Ross Nash

8/20/2010

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accretions by application of chemical agents and actions and makes determinations on a case by case basis. TN: According to ADA DSGA, the BOD's General Rules provide that all teeth whitening formulations, except those sold over the counter, shall be prescribed by a dentist. UT: State licensing agency Division of Occupational and Professional Licensing (DOPL) ruled some years ago that non-dentists, regardless of the location can sell tooth-whitening materials and kits; can instruct regarding their application and use; cannot do anything inside the mouth, nor physically assist in making trays or molds.

Dental Board Opinions •

CA "The board which operates under the state Department of Consumer Affairs, found that businesses were not violating state law, because the bleaching agent is far less than prescription strength and the lights customers sit under are similar to a flashlight bulb. Also, operators do not touch the client's mouths, which by law would be dentistry. (Strindberg, A. "New teeth-whitening shops operate in gray area," the Press Enterprise (Riverside, Calif.) May 10,2008.)



FL: from September 14, 2007 BOD Minutes: "Board merrlbers responded by stating that "Anyone who performs bleaching services (salons, spas, etc.) is practicing dentistry pursuant to their interpretation of the definition of dentistry ... Motion, that board affirm that bleaching constitutes the practice of dentistry. Vote unanimous"



ME: Individuals providing this service may be practicing dentistry without a license in violation of32 MSRA § 1081."



NM: BOD is reviewing "as we speak."



NJ: FEBRUARY 7,2007: The Board reviewed a letter from a dentist requesting interpretation of the Board's regulation concerning delegable duties for hygienists in teeth whitening procedures. The Board determined that teeth whitening procedures must be performed by the dentist and such services can only be provided by a practice owned and operated by New Jersey licensed dentists along with closely allied licensed health care professionals. Dental hygienists may not provide these services independently. OCTOBER 3,2007: The committee reviewed correspondence from a dentist requesting the criteria to open a Zoom clinic or spa. The committee noted the Board has previously determined that a dentist must be on the premises and obtain a branch office license for that location. This location must meet all requirements of a regular dental office. NOVEMBER 7, 2007. The Board reviewed a request for clarification with regard to RDHs and RDAs being able to apply whitening gels for in-office bleaching. The Board determined that both registered dental hygienists and registered dental assistants may apply the gel and hold the light (not laser) at the direction of a licensed dentist. DECEMBER 5, 2007: The Board advised that teeth bleaching is the practice of dentistry and must be performed by a dentist. Such procedure should be done in a facility with appropriate dental equipment, including but not limited to equipment necessary for examination, sterilization, treatment, etc.

This document is intended as an informational resource on legal actions taken by states involving tooth whitening by non-dentists. The information is to promote understanding and should be used freely, but the document itself should not be reproduced or distributed without permission from the ~ADA Division of Legal Affairs.

002611

1261

CX0488-049

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1262

Pg: 249 of 366

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Appeal: 12-1172

Doc: 63-4

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1263

Pg: 250 of 366

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1264

Pg: 251 of 366

CX0513-003

Appeal: 12-1172

Doc: 63-4

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1265

Pg: 252 of 366

CX0513-004

Appeal: 12-1172

Doc: 63-4

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1266

Pg: 253 of 366

CX0513-005

Appeal: 12-1172

Doc: 63-4

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1267

Pg: 254 of 366

CX0513-006

Appeal: 12-1172

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1268

Pg: 255 of 366

CX0513-007

Appeal: 12-1172

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1269

Pg: 256 of 366

CX0513-008

Appeal: 12-1172

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1270

Pg: 257 of 366

CX0513-009

Appeal: 12-1172

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1271

Pg: 258 of 366

CX0513-010

Appeal: 12-1172

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1272

Pg: 259 of 366

CX0513-011

Appeal: 12-1172

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1273

Pg: 260 of 366

CX0513-012

Appeal: 12-1172

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1274

Pg: 261 of 366

CX0513-013

Appeal: 12-1172

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1275

Pg: 262 of 366

CX0513-014

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1276

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1277

Pg: 264 of 366

CX0513-016

Appeal: 12-1172

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1278

Pg: 265 of 366

CX0513-017

Appeal: 12-1172

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1279

Pg: 266 of 366

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1280

Pg: 267 of 366

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1281

Pg: 268 of 366

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1282

Pg: 269 of 366

CX0513-021

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1283

Pg: 270 of 366

CX0513-022

Appeal: 12-1172

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1284

Pg: 271 of 366

CX0513-023

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1285

Pg: 272 of 366

CX0513-024

Appeal: 12-1172

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1286

Pg: 273 of 366

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1287

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1288

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1289

Pg: 276 of 366

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1290

Pg: 277 of 366

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1291

Pg: 278 of 366

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1292

Pg: 279 of 366

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1293

Pg: 280 of 366

CX0513-032

Appeal: 12-1172

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1294

Pg: 281 of 366

CX0513-033

Appeal: 12-1172

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1295

Pg: 282 of 366

CX0513-034

Appeal: 12-1172

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1296

Pg: 283 of 366

CX0513-035

Appeal: 12-1172

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1297

Pg: 284 of 366

CX0513-036

Appeal: 12-1172

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1298

Pg: 285 of 366

CX0513-037

Appeal: 12-1172

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1299

Pg: 286 of 366

CX0513-038

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1300

Pg: 287 of 366

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1301

Pg: 288 of 366

CX0513-040

Appeal: 12-1172

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1302

Pg: 289 of 366

CX0513-041

Appeal: 12-1172

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1303

Pg: 290 of 366

CX0513-042

Appeal: 12-1172

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Appeal: 12-1172

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1305

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CX0513-044

Appeal: 12-1172

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1306

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1307

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CX0513-046

Appeal: 12-1172

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1308

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CX0513-047

Appeal: 12-1172

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1309

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CX0513-048

Appeal: 12-1172

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1310

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Appeal: 12-1172

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1311

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1312

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1313

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Appeal: 12-1172

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Appeal: 12-1172

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CX0513-054

Appeal: 12-1172

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CX0513-055

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Doc: 63-4

Filed: 07/06/2012

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CX0513-056

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CX0513-057

Appeal: 12-1172

Doc: 63-4

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CX0513-058

Appeal: 12-1172

Doc: 63-4

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CX0513-059

Appeal: 12-1172

Doc: 63-4

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CX0513-060

Appeal: 12-1172

Doc: 63-4

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CX0513-061

Appeal: 12-1172

Doc: 63-4

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Appeal: 12-1172

Doc: 63-4

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CX0513-065

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Appeal: 12-1172

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Doc: 63-4

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CX0513-080

Appeal: 12-1172

Doc: 63-4

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CX0513-081

Appeal: 12-1172

Doc: 63-4

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CX0513-082

Appeal: 12-1172

Doc: 63-4

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CX0513-083

Appeal: 12-1172

Doc: 63-4

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CX0513-084

Appeal: 12-1172

Doc: 63-4

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CX0513-085

Appeal: 12-1172

Doc: 63-4

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CX0513-086

Appeal: 12-1172

Doc: 63-4

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CX0513-087

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

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NORul CAROLINA STATE BOARD OF DENT•.!.L E.."IU...'\1Th'ERS w. STAN IlARDlS'lYt DJ).S.., Ptaidc:aJ: RONALiJ K. OWENS, D~ Stac&lry~TrQ~ JOSEPH S. JL'RNHAM., D.IJ..S., Put PtcmdeGt ZA_NNIE P. £!I'!!tD, ,.-~ ~

CLiiijf()1U> O. FEINGOLD. D.D.S. C. \VA..."l'...'E HOu...;..ru;., D.b.s. Jl;R.....D C. MORGA."'!.D..D.8. NEPLUS S. BALI..,. R.D:a

January i3, 2008 Dr. tyficha.el A Catanese 135 Fe-uill Place Charlotte NC 28207

Re: Tooth W-lritening Kiosks Dear Dr. Catanese:

You will find enclosed a copy of a letter that the Dental Board has written to tb.e .manugement of Carolina Place Mall regarding the improper whitening of teeL~ by nou~ dentists. Staff wrote to the Chicago compiulY t.hat OW!IS Carolina Place M:all about the subject in Novenlber 2007.

'

Please let US know if the practice c.nntinues and if we may be of additionai service. Thank you for drawing this m::atter to our attention.

Very tr111 Y YOi.il1i,

/I

r.

~~

Carolin Bakeweil Board Counsel

507 AJRPORT BOULEVARD, SUITIi: 105 • M'ORJUSvrLLI,. NORTI! CA!'!:OL."N:" n~w n..LilrnVA'& i)l1,j

~71-1l2:J'

FAX (9")47I-U71·I;MAIL.llnl't,,'ilardt,t.'ttpu4 prr· 1rn'll'.ftdt.lltalbo...d.ClI'J

NC80AR0888

1349

CX0524-001

Appeal: 12-1172

Doc: 63-4

Filed: 07/06/2012

Pg: 337 of 366

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1062 - Applied Antitrust Law

Appeal: 12-1172 Doc: 63-4 Filed: 07/06/2012 Pg: 1 of 366 CASE NO. 12-1172 ________________________ IN THE UNITED STATES COURT OF APPEALS FOR THE F...

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