OMNIPLASTIC BONE CEMENT
FDA premarket approval N17113 · decided 1981-09-16
Approval details
- PMA number
- N17113
- Trade name
- OMNIPLASTIC BONE CEMENT
- Generic name
- BONE CEMENT
- Applicant
- L.D. Caulk Co.
- Date received
- 1981-02-27
- Decision date
- 1981-09-16
- Days to decision
- 201 days
- Decision code
- APRL
- Product code
- LOD
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Milford, DE
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| COMPOSITE RESTORATIVE (K802262) | L.D. Caulk Co. | 1980-09-16 |
| VALIANT (K801690) | L.D. Caulk Co. | 1980-08-13 |
| FINESSE (K790585) | L.D. Caulk Co. | 1979-05-16 |
| CHEMBOND (K790586) | L.D. Caulk Co. | 1979-05-16 |
| DENTAL AMALGAMATOR (K780560) | L.D. Caulk Co. | 1978-04-21 |
| IMPROVED DYCAL (K780384) | L.D. Caulk Co. | 1978-03-15 |
| CAULK TYLOK (K780301) | L.D. Caulk Co. | 1978-02-28 |
| LIP & CHEEK RETRACTOR (K771399) | L.D. Caulk Co. | 1977-08-26 |