K050710 is an FDA 510(k) clearance for the MINIMASTER ULTRASONIC SCALER. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by E.M.S Electro Medical Systems S.A (North Attleboro, US). The FDA issued a Cleared decision on March 30, 2005, 12 days after receiving the submission on March 18, 2005.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K050710 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 2005 |
| Decision Date | March 30, 2005 |
| Days to Decision | 12 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELC — Scaler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4850 |