Submission Details
| 510(k) Number | K151023 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
COMPACT PIEZO LED
Aug 2015
Decision
111d
Days
Class 2
Risk
About This 510(k) Submission
K151023 is an FDA 510(k) clearance for the COMPACT PIEZO LED, 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 review panel. Regulated under 21 CFR 872.4850.
Device Classification
| Product Code | ELC — Scaler, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.4850 |
Manufacturer
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