K954690 is an FDA 510(k) clearance for the STRYKER ORAL MAX SYSTEM. This device is classified as a Drill, Bone, Powered (Class II - Special Controls, product code DZI).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on August 20, 1996, 314 days after receiving the submission on October 11, 1995.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K954690 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 1995 |
| Decision Date | August 20, 1996 |
| Days to Decision | 314 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZI — Drill, Bone, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |