K102218 is an FDA 510(k) clearance for the COMPACT PIEZO P2K, POWERCARE. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Mectron S.P.A. (Rome, IT). The FDA issued a Cleared decision on January 24, 2011, 171 days after receiving the submission on August 6, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K102218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2010 |
| Decision Date | January 24, 2011 |
| Days to Decision | 171 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 |