2002P-0520 - Dental Devices; Tricalcium Phosphate Granules and Other Bone Grafting Material for Dental Bone Repair
FDA Comment Number : EC1
Submitter : Dr. Wayne Wozniak Date & Time: 10/04/2004 04:10:17
Organization : American Dental Association
Health Care Association
Category :
Issue Areas/Comments
PROPOSED COMMENTS TO FEDERAL REGISTER Docket No 2002P-0520 - Food And Drug Administration 21 CFR Part 872 - VOL. 69, NO.125, p.39377.

The American Dental Association has reviewed the FDA request for comments on the proposal to reclassify tricalcium phosphate (TCP) granules for dental bone repair from class III to class II (special controls); classify into class II (special controls) all other bone grafting material for dental indications, except those that contain drug or biologic components; and revise the classification name and identification of the device. The Association is of the opinion that this reclassification is not sufficient to provide reasonable assurance of the safety and effectiveness of these devices and that these materials should remain in class III (premarket approval).

If these devices were reclassified into class II, compliance with a Special Controls Guidance Document on Dental Bone Grafting Material would be required for a 510(k) premarket notification. However, the proposed guidance document relies only on composition, physical properties and compliance with ASTM composition standards for evidence of safety and effectiveness. The American Dental Association in its Acceptance Program Guidelines for these devices, in addition to biological, physical and chemical properties of the material, requires reports on two independent clinical studies over a period of two years. In this manner criteria such as histological response, evidence of resorption, and mucosal health over the implant area can be evaluated. At this time, the Association strongly believes that only evidence from clinical studies is sufficient to provide reasonable assurance of the safety and effectiveness of these devices and therefore these devices should not be reclassified.