K970953 is an FDA 510(k) clearance for the E-TYPE SPEED REDUCER CONTRA ANGLE. This device is classified as a Handpiece, Rotary Bone Cutting (Class II - Special Controls, product code KMW).
Submitted by Nsk Nakanishi, Inc. (Tochigi-Ken, JP). The FDA issued a Cleared decision on April 15, 1997, 29 days after receiving the submission on March 17, 1997.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K970953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 1997 |
| Decision Date | April 15, 1997 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | KMW — Handpiece, Rotary Bone Cutting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |