STERI-OSS SINUS AUGMENTATION KIT
FDA 510(k) clearance K963897 · decided 1996-11-06
Clearance details
- K-number
- K963897
- Device name
- STERI-OSS SINUS AUGMENTATION KIT
- Applicant
- Steri-Oss, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-09-27
- Decision date
- 1996-11-06
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- EMM
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Yorba Linda, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.