K032395 is an FDA 510(k) clearance for the PROPHY-MATE. This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).
Submitted by Nakanishi, Inc. (Kanuma-Shi, JP). The FDA issued a Cleared decision on October 17, 2003, 74 days after receiving the submission on August 4, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K032395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2003 |
| Decision Date | October 17, 2003 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EFB — Handpiece, Air-powered, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |