K211584 is an FDA 510(k) clearance for the Oral Surgery Contra. This device is classified as a Handpiece, Rotary Bone Cutting (Class II - Special Controls, product code KMW).
Submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on August 19, 2021, 87 days after receiving the submission on May 24, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K211584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2021 |
| Decision Date | August 19, 2021 |
| Days to Decision | 87 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 |