K251425 is an FDA 510(k) clearance for the turbodent touch. This device is classified as a Airbrush (Class II - Special Controls, product code KOJ).
Submitted by Mectron S.P.A. (Carasco, IT). The FDA issued a Cleared decision on May 9, 2025, 1 day after receiving the submission on May 8, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6080.
| 510(k) Number | K251425 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2025 |
| Decision Date | May 09, 2025 |
| Days to Decision | 1 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KOJ - Airbrush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6080 |