K022328 is an FDA 510(k) clearance for the EMS PIEZON MASTER 600. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Electro Medical Systems SA (North Attleboro, US). The FDA issued a Cleared decision on August 13, 2002, 26 days after receiving the submission on July 18, 2002.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K022328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2002 |
| Decision Date | August 13, 2002 |
| Days to Decision | 26 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 |