Dental devices; reclassification of tricalcium phosphate granules and classification of other bone grafting material for dental bone repair. Final rule.
The Food and Drug Administration (FDA) is reclassifying tricalcium phosphate (TCP) granules for dental bone repair from class III to class II (special controls), classifying into class II (special controls) other bone grafting material for dental indications, and revising the classification name and identification of the device type. Bone grafting materials that contain a drug that is a therapeutic biologic will remain in class III and continue to require a premarket approval application. The classification identification includes materials such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen. This action is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the class II devices.
D018786:Bone Substitutes / Q000145:classification*; D016025:Bone Transplantation; D002130:Calcium Phosphates / Q000145:classification*; D003094:Collagen / Q000145:classification; D003764:Dental Materials / Q000145:classification*; D017886:Durapatite / Q000145:classification; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D019344:Lactic Acid / Q000145:classification; D011100:Polyglycolic Acid / Q000145:classification; D011108:Polymers / Q000145:classification; D014481:United States; D014486:United States Food and Drug Administration
D018786:Bone Substitutes; D002130:Calcium Phosphates; D003764:Dental Materials; D011108:Polymers; D011100:Polyglycolic Acid; D019344:Lactic Acid; D003094:Collagen; D017886:Durapatite