Food and Drug Administration

Dental Products Panel

May 22, 2003

Briefing Information

General Device Classification Questionnaire (PDF)

Supplemental Data Sheet (PDF)

Cover Letter from Michael E. Adjodha (HTM) (PDF) (Word)

Adverse Reports on Tr-Calcium Phosphate Dental Device (HTM) (PDF) (RTF)

Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA (HTM) (PDF) (Word)

BCTP Petition Review Summary (HTM) (PDF) (Word)