K181110 is an FDA 510(k) clearance for the PROPHYflex 4. This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).
Submitted by Kaltenbach & Voigt GmbH (Biberach, DE). The FDA issued a Cleared decision on April 10, 2019, 348 days after receiving the submission on April 27, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K181110 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2018 |
| Decision Date | April 10, 2019 |
| Days to Decision | 348 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EFB - Handpiece, Air-powered, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |