PEPGEN P-15, PEPGEN P-15 FLOW, AND PEPGEN P-15 PUTTY
FDA premarket approval P990033/S005 · decided 2004-03-15
Approval details
- PMA number
- P990033
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PEPGEN P-15, PEPGEN P-15 FLOW, AND PEPGEN P-15 PUTTY
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Ceramed Corp.
- Date received
- 2003-11-12
- Decision date
- 2004-03-15
- Days to decision
- 124 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Lakewood, CO
- Statement
- APPROVAL FOR: 1) THE ADDITION OF A PASTE FORM OF PEPGEN P-15, 2) MODIFICATION OF THE DEVICE LABELING FOR ALL PEPGEN P-15 DEVICES, AND 3) CHANGING OF THE CONTRACT MANUFACTURER FOR THE DEVICE CARRIER TO HYALURON, INC., WOBURN, MASSACHUSETTS.
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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 |