Submission Details
| 510(k) Number | K102218 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
COMPACT PIEZO P2K, POWERCARE
Jan 2011
Decision
171d
Days
Class 2
Risk
About This 510(k) Submission
K102218 is an FDA 510(k) clearance for the COMPACT PIEZO P2K, POWERCARE, 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 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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