EMM
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Chisel, Osteotome, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STERI-OSS SINUS AUGMENTATION KIT (K963897) | Steri-Oss, Inc. | 1996-11-06 |
| CHISEL (OSTEOTOME, GOUGE, ETC.) (K864775) | New England Surgical Instrument Corp. | 1987-02-12 |
| 820/1 TO 820/51 VARIOUS TYPES BONE RONGEURS (K851714) | Artiberia | 1985-06-11 |
| SURGICAL CHISEL (K760959) | American Safety Equipment Corp. | 1976-11-15 |
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Every clearance here is in the API, with alerts when new ones post.