PEPGEN P-15 DENTAL BONE GRAFTING MATERIAL AND BIOLOGIC COMPONENT
FDA premarket approval P990033/S007 · decided 2006-06-06
Approval details
- PMA number
- P990033
- Supplement
- S007
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PEPGEN P-15 DENTAL BONE GRAFTING MATERIAL AND BIOLOGIC COMPONENT
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Ceramed Corp.
- Date received
- 2006-05-22
- Decision date
- 2006-06-06
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Lakewood, CO
- Statement
- APPROVAL FOR THE CHANGE IN INDICATION FOR USE - THE DEVICE IS NO LONGER INTENDED FOR REUSE AFTER RESTERILIZATION AND WILL BE LABELED AS A SINGLE USE ONLY DEVICE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PERMARIDGE SYRINGE (K962838) | Ceramed Corp. | 1996-08-20 |
| OSTEOGRAF STAINLESS STEEL SYRING (K962786) | Ceramed Corp. | 1996-08-01 |
| OSTEOGRAF/N-300 HYDROXYLAPATITE (K960348) | Ceramed Corp. | 1996-04-22 |
| OSTEOGRAFT/N-700 HYDROXYLAPTITE (K960368) | Ceramed Corp. | 1996-04-18 |
| OSTEOGRAF/LD-300 HYDROXYLAPATITE (K960353) | Ceramed Corp. | 1996-04-18 |
| PERMAMESH-D HYDROXYLAPATITE MATRIX (K960361) | Ceramed Corp. | 1996-04-15 |
| PERMAMESH HYDROXYLAPATITE MATRIX (K960362) | Ceramed Corp. | 1996-03-20 |
| PERMAMESH-D HYDROXYLAPATITE MATRIX (K960354) | Ceramed Corp. | 1996-03-20 |