PEPGEN P-15 AND PEPGEN P-15 FLOW
FDA premarket approval P990033/S004 · decided 2002-06-14
Approval details
- PMA number
- P990033
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PEPGEN P-15 AND PEPGEN P-15 FLOW
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Ceramed Corp.
- Date received
- 2002-04-22
- Decision date
- 2002-06-14
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Lakewood, CO
- Statement
- APPROVAL FOR THE ADDITION OF THE FOLLOWING INDICATIONS FOR USE; AUGMENTATION OF BONY DEFECTS OF THE ALVEOLAR RIDGE, FILLING TOOTH EXTRACTION SITES, AND SINUS ELEVATION GRAFTING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES PEPGEN P-15 AND PEPGEN P-15 FLOW.
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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 |