U.S. Food and Drug Administration

 

THE MEDICAL DEVICE ADVISORY COMMITTEE

MEETING OF THE

DENTAL PRODUCTS PANEL

 

 

 

 

 

Holiday Inn Gaithersburg

Walker/Whetstone Salons

Gaithersburg, Maryland

Thursday, May 22, 2003


U.S. Food and Drug Administration

 

DRAFT MEETING AGENDA

DENTAL PRODUCTS PANEL

Holiday Inn Gaithersburg

Walker/Whetstone Salons

Gaithersburg, MD

Thursday, May 22, 2003

 

9:30 a.m.                      CALL TO ORDER

9:30 – 9:45 a.m.           OPEN SESSION -- Welcome and Introductory Remarks

·        Michael E. Adjodha, Executive Secretary

·        Dr. Leslie B. Heffez, Chairman

9:45 - 10:15 a.m.          FDA Presentation – Reclassification of Tricalcium Phosphate Granules for Dental Bone Repair (21 CFR 872.3930)

·        Dr. Kevin P. Mulry, Acting Chief, Dental Devices Branch, DAGID

·        Dr. Robert S. Betz, Lead Reviewer, Dental Devices Branch

10:15 - 11:15 a.m.        Sponsor Presentation – Petition to Reclassify 21 CFR 872.3930

·        Dr. Vincent J. Morgan – The Petitioner

·        Mr. Thomas Driskell – Inventor

·        Dr. John R. Long – Chemist

11:15 - 12:15 p.m.       Open Public Hearing

·        Dr. Gunter Uhr – Curasan AG

·        Dr. Thomas Arrowsmith-Lowe – Regulatory Consultant for Curasan AG

·        Dr. Barbara Boyan – American Academy of Dental Research

·        Dr. Mark A. Reynolds – American Academy of Periodontology

 

12:15 - 1:15 p.m.         LUNCH

1:15 - 2:15 p.m.           Panel Presentation/Discussion

2:15 - 2:30 p.m.           BREAK

2:30 - 4:00 p.m.           Panel Recommendation and Classification

·        Ms. Marjorie Shulman, Consumer Safety Officer, FDA

4:00 p.m.                      CLOSED SESSION – Dental Branch Updates

4:30 p.m.                      MEETING ADJOURNED 


 

The Medical Device Advisory Committee

Meeting of the Dental Products Panel

 

Thursday, May 22, 2003

                                                   

 

CHAIR

EXECUTIVE SECRETARY

 

Leslie B. Heffez, DMD, MS

Professor & Head, Oral/Maxillofacial Surgery

University of Illinois, College of Dentistry

Chicago, Illinois     

 

Michael E. Adjodha, M.ChE.

Department of Health and Human Services

Food and Drug Administration        

Center for Devices and Radiological Health

Office of Device Evaluation

Division of Anesthesiology, General Hospital,

Infection Control, and Dental Devices

 

                                                 

 

PANEL MEMBERS

 

Name

Affiliation

Role

 

Richard G. Burton, D.D.S

University of Iowa, Department of Hospital Dentistry

Iowa City, Iowa

Consultant

Deputized to Vote

David L. Cochran, D.D.S., Ph.D.

University of Texas, Health Science Center

San Antonio, Texas

Voting Member

 

Julianne Glowacki, Ph.D.         

Brigham and Woman’s Hospital

Boston, Massachusetts

Consultant

Deputized to Vote

Edmond R. Hewlett, D.D.S.

UCLA, School of Dentistry

Los Angeles, California

Consultant

Deputized to Vote

Elizabeth S. Howe

National Foundation for Ectodermal Dysplasias

Auburn, Washington

Consumer Representative

Non-voting Member

Mark R. Patters, D.D.S., Ph.D.

 

University of Tennessee, College of Dentistry

Memphis,  Tennessee

Consultant

Deputized to Vote

E. Diane Rekow, D.D.S., Ph.D.

New York University, College of Dentistry

New York, New York

Voting Member

 

Daniel R. Schechter, J.D.

Parkell, Inc.

Farmingdale, New York

Industry Representative

Non-voting Member

Jon B. Suzuki, D.D.S., Ph.D.

University of Pittsburgh, School of Dentistry

Pittsburgh, Pennsylvania

Voting Member

 

 

 

 

 

 

         


 

 

FDA PARTICIPANTS

 

M. Susan Runner, D.D.S., M.A., Captain, USPHS

Interim Division Director, DAGID

DHHS/FDA/CDRH/ODE

Kevin P. Mulry, D.D.S., M.P.H.

Acting Branch Chief

Dental Devices Branch

DHHS/FDA/CDRH/ODE

Robert S. Betz, D.D.S., Captain, USPHS

Dental Officer

Dental Devices Branch

DHHS/FDA/CDRH/ODE

Marjorie Shulman

Consumer Safety Officer

Premarket Notification Staff

DHHS/FDA/CDRH/ODE

Michael E. Adjodha, M.ChE.

Chemical Engineer

Dental Devices Branch

DHHS/FDA/CDRH/ODE

 

 

 

 

SPONSOR PARTICIPANTS

 

Vincent J. Morgan, D.M.D.

President

Bicon, Inc.

Boston, Massachusetts

Thomas Driskell

Inventor

Westerville, Ohio 

John R. Long, Ph.D.

Director of Technology

GFS Chemicals, Inc.

Columbus, Ohio 

 

 

 

 

 

 

 

 

 

 

 


BACKGROUND

 

Dr. Vincent J. Morgan, President of Bicon, Inc., Boston, Massachusetts, submitted a petition to the FDA on November 12, 2002, to reclassify beta-tricalcium phosphate for dental indications.  Beta-tricalcium phosphate and all other forms of tricalcium phosphate, i.e., alpha, amorphous, etc., are transitional devices and are currently regulated for dental indications as a Class III devices under 21 CFR 872.3930, “Tricalcium Phosphate Granules for Dental Bone Repair.”  As modified on December 9, 2002, Dr. Morgan’s petition requests that beta-tricalcium phosphate be regulated as a Class II device.  Copies of the petition are available on FDA’s docket.  See http://www.fda.gov/ohrms/dockets/dailys/02/Dec02/121702/02p-0520.pdf. 

 

To address the petitioner’s request, the FDA has arranged to meet with a classification panel on May 22, 2003, in accordance with the procedures set forth for transitional devices (21 CFR 860.136), to reclassify 21 CFR 872.3930, the regulation to which beta tricalcium phosphate belongs.  For the purposes of this meeting, all forms of tricalcium phosphate, are subject to the proposed reclassification.

 

PANEL ACTION

 

At this meeting, the Dental Products Panel will discuss and vote on the following:

·                          Dr. Morgan’s petition,

·                          The risks of tricalcium phosphate (as defined in 21 CFR 872.3930),

·                          Any recommended controls for this device,

·                          A reclassification of the device, and

·                          Any recommended changes to the labeling and indications for use.

 


QUESTIONS FOR THE DENTAL PRODUCTS PANEL REGARDING THE PETITION TO RECLASSIFY TRICALCIUM PHOSHATE.

 

 

Dr. Vincent J. Morgan of Bicon, Inc., has submitted a petition to reclassify beta-tricalcium phosphate from Class III (Pre-Market Approval) to Class II (Special Controls).

 

Tricalcium phosphate is regulated as a Class III device under 21 CFR 872.3930, product code LPK, “Tricalcium Phosphate Granules for Dental Bone Repair.”  Please consider the following questions for Panel discussion.

 

1.                  Does the petition, as filed, adequately describe the risks to health of the device and provide for appropriate controls for these risks?  If yes, proceed to 3.  If no, go to 2.

 

2.                  a) What modifications would you make to the risks to health presented by the device?

b) What controls for these risks would provide a reasonable assurance of safety and effectiveness?  Proceed to 3.

 

3.                  Please complete the Classification Questionnaire and Supplemental Data Sheet for the device.  Completion of these forms will provide a formal recommendation for the reclassification of “Tricalcium Phosphate Granules for Dental Bone Repair.” (21 CFR 872.3930).  Proceed to 4.

 

4.                  Given your recommended classification, what changes, if any, would you recommend be made to the labeling (includes directions for use, indications, and contraindications) of these devices?