K151023 is an FDA 510(k) clearance for the COMPACT PIEZO LED. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Mectron S.P.A. (Carasco, IT). The FDA issued a Cleared decision on August 5, 2015, 111 days after receiving the submission on April 16, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K151023 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2015 |
| Decision Date | August 05, 2015 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELC - Scaler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4850 |