K963897 is an FDA 510(k) clearance for the STERI-OSS SINUS AUGMENTATION KIT. This device is classified as a Chisel, Osteotome, Surgical (Class I - General Controls, product code EMM).
Submitted by Steri-Oss, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on November 6, 1996, 40 days after receiving the submission on September 27, 1996.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K963897 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 1996 |
| Decision Date | November 06, 1996 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EMM — Chisel, Osteotome, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |