ALVEOFORM TM BIOGRAFT
FDA premarket approval P860012/S001 · decided 1988-12-13
Approval details
- PMA number
- P860012
- Supplement
- S001
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ALVEOFORM TM BIOGRAFT
- Generic name
- BONE GRAFTING MATERIAL, ANIMAL SOURCE
- Applicant
- Collagen Corp.
- Date received
- 1988-11-09
- Decision date
- 1988-12-13
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- NPM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Palo Alto, CA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| QAR HANDPIECE (K904671) | Collagen Corp. | 1990-12-21 |
| OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED) (K904228) | Collagen Corp. | 1990-11-09 |
| OSSEOTITE IRRIGATION UNIT (K901600) | Collagen Corp. | 1990-06-21 |
| OSSEODENT DENTAL ATTACHMENT, IGLOO MAGNET (K900275) | Collagen Corp. | 1990-04-19 |
| OSSEODENT DENTAL ATTACHMENTS (K895462) | Collagen Corp. | 1990-04-04 |
| OSSEODENT(R) PRECISION DENTAL ATTACHMENTS (K895463) | Collagen Corp. | 1990-03-28 |
| OSSEODENT SURGICAL KIT (K894331) | Collagen Corp. | 1989-10-04 |
| DENTAL HAND INSTRUMENTS (K883322) | Collagen Corp. | 1988-08-26 |