Food and Drug Administration

Medical Devices Advisory Committee

Dental Products Panel

July 13, 2004

Briefing Information

Memorandum Regarding Analysis of Adverse Event Reports (PDF)

Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Dental Bone Grafting Material (PDF)

Federal Register Notice, Vol 69, No. 125, June 30, 2004, 21 CFR Part 872 Dental Devices; Tricalcium Phosphate Granules and Other Bone Repair (PDF)

Sponsor's Briefing Document, Vol. I, BioMimetic Pharmaceuticals (PDF)

Sponsor's Briefing Document, Vol. II, BioMimetic Pharmaceuticals (PDF)