- Device
- PEPGEN P-15, PEPGEN P-15 FLOW & PEPGEN P-15 PUTTY
- Applicant
- Ceramed Corp.
- PMA number
- P990033
- Supplement
- S014
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2007-08-09
- Decision code
- APPR
- Date received
- 2007-01-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO RELOCATE THE MANUFACTURING SITE TO DENTSPLY SPECIALTY MATERIALS LOCATED IN YORK PENNSYLVANIA.