K171155 is an FDA 510(k) clearance for the Surgical Angle Handpiece, Surgical Straight Handpiece. This device is classified as a Handpiece, Rotary Bone Cutting (Class II - Special Controls, product code KMW).
Submitted by Nakanishi, Inc. (Kanuma-Shi, JP). The FDA issued a Cleared decision on November 21, 2017, 215 days after receiving the submission on April 20, 2017.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K171155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 2017 |
| Decision Date | November 21, 2017 |
| Days to Decision | 215 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KMW — Handpiece, Rotary Bone Cutting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |