![](media/image1.png){width="6.020833333333333in" height="0.6875in"}

**THE MEDICAL DEVICE ADVISORY COMMITTEE**

**MEETING OF THE**

**DENTAL PRODUCTS PANEL**

**Holiday Inn Gaithersburg**

**Walker/Whetstone Salons**

**Gaithersburg, Maryland**

**Thursday, May 22, 2003**

![](media/image1.png){width="6.020833333333333in" height="0.6875in"}

**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     | Michael E. Adjodha, M.ChE.            |
|                               |                                       |
| Professor & Head,             | Department of Health and Human        |
| Oral/Maxillofacial Surgery    | Services                              |
|                               |                                       |
| University of Illinois,       | Food and Drug Administration          |
| College of Dentistry          |                                       |
|                               | Center for Devices and Radiological   |
| Chicago, Illinois             | Health                                |
|                               |                                       |
|                               | Office of Device Evaluation           |
|                               |                                       |
|                               | Division of Anesthesiology, General   |
|                               | Hospital,                             |
|                               |                                       |
|                               | Infection Control, and Dental Devices |
+-------------------------------+---------------------------------------+

                                                 

**PANEL MEMBERS**

+-----------------+---+---+-----------------------+------+---------+---+-----+
| **Name**        |   |   | **Affiliation**       |      | *       |   |     |
|                 |   |   |                       |      | *Role** |   |     |
+=================+===+===+=======================+======+=========+===+=====+
| Richard G.      |   |   | University of Iowa,   |      | Con     |   |     |
| Burton, D.D.S   |   |   | Department of         |      | sultant |   |     |
|                 |   |   | Hospital Dentistry    |      |         |   |     |
|                 |   |   |                       |      | De      |   |     |
|                 |   |   | Iowa City, Iowa       |      | putized |   |     |
|                 |   |   |                       |      | to Vote |   |     |
+-----------------+---+---+-----------------------+------+---------+---+-----+
| David L.        |   |   | University of Texas,  |      | Voting  |   |     |
| Cochran,        |   |   | Health Science Center |      | Member  |   |     |
| D.D.S., Ph.D.   |   |   |                       |      |         |   |     |
|                 |   |   | San Antonio, Texas    |      |         |   |     |
+-----------------+---+---+-----------------------+------+---------+---+-----+
| Julianne        |   |   | Brigham and Woman's   |      | Con     |   |     |
| Glowacki,       |   |   | Hospital              |      | sultant |   |     |
| Ph.D.           |   |   |                       |      |         |   |     |
|                 |   |   | Boston, Massachusetts |      | De      |   |     |
|                 |   |   |                       |      | putized |   |     |
|                 |   |   |                       |      | to Vote |   |     |
+-----------------+---+---+-----------------------+------+---------+---+-----+
| Edmond R.       |   |   | UCLA, School of       |      | Con     |   |     |
| Hewlett, D.D.S. |   |   | Dentistry             |      | sultant |   |     |
|                 |   |   |                       |      |         |   |     |
|                 |   |   | Los Angeles,          |      | De      |   |     |
|                 |   |   | California            |      | putized |   |     |
|                 |   |   |                       |      | to Vote |   |     |
+-----------------+---+---+-----------------------+------+---------+---+-----+
| Elizabeth S.    |   |   | National Foundation   |      | C       |   |     |
| Howe            |   |   | for Ectodermal        |      | onsumer |   |     |
|                 |   |   | Dysplasias            |      | Represe |   |     |
|                 |   |   |                       |      | ntative |   |     |
|                 |   |   | Auburn, Washington    |      |         |   |     |
|                 |   |   |                       |      | Non     |   |     |
|                 |   |   |                       |      | -voting |   |     |
|                 |   |   |                       |      | Member  |   |     |
+-----------------+---+---+-----------------------+------+---------+---+-----+
| Mark R.         |   |   | University of         |      | Con     |   |     |
| Patters,        |   |   | Tennessee, College of |      | sultant |   |     |
| D.D.S., Ph.D.   |   |   | Dentistry             |      |         |   |     |
|                 |   |   |                       |      | De      |   |     |
|                 |   |   | Memphis, Tennessee    |      | putized |   |     |
|                 |   |   |                       |      | to Vote |   |     |
+-----------------+---+---+-----------------------+------+---------+---+-----+
| E. Diane Rekow, |   |   | New York University,  |      | Voting  |   |     |
| D.D.S., Ph.D.   |   |   | College of Dentistry  |      | Member  |   |     |
|                 |   |   |                       |      |         |   |     |
|                 |   |   | New York, New York    |      |         |   |     |
+-----------------+---+---+-----------------------+------+---------+---+-----+
| Daniel R.       |   |   | Parkell, Inc.         |      | I       |   |     |
| Schechter, J.D. |   |   |                       |      | ndustry |   |     |
|                 |   |   | Farmingdale, New York |      | Represe |   |     |
|                 |   |   |                       |      | ntative |   |     |
|                 |   |   |                       |      |         |   |     |
|                 |   |   |                       |      | Non     |   |     |
|                 |   |   |                       |      | -voting |   |     |
|                 |   |   |                       |      | Member  |   |     |
+-----------------+---+---+-----------------------+------+---------+---+-----+
| Jon B. Suzuki,  |   |   | University of         |      | Voting  |   |     |
| D.D.S., Ph.D.   |   |   | Pittsburgh, School of |      | Member  |   |     |
|                 |   |   | Dentistry             |      |         |   |     |
|                 |   |   |                       |      |         |   |     |
|                 |   |   | Pittsburgh,           |      |         |   |     |
|                 |   |   | Pennsylvania          |      |         |   |     |
+-----------------+---+---+-----------------------+------+---------+---+-----+
|                 |   |   |                       |      |         |   |     |
+-----------------+---+---+-----------------------+------+---------+---+-----+

         

> ** **

+-----------------------------------------------------------------------+
| **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>[.]{.underline}

[]{.mark}

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.

[]{.mark}

**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?