The following data is part of a premarket notification filed by Mectron S.p.a. with the FDA for Compact Piezo P2k, Powercare.
| Device ID | K102218 |
| 510k Number | K102218 |
| Device Name: | COMPACT PIEZO P2K, POWERCARE |
| Classification | Scaler, Ultrasonic |
| Applicant | MECTRON S.P.A. PIAZZA ALBANIA 10 Rome, IT 00153 |
| Contact | Roger Gray |
| Correspondent | Roger Gray MECTRON S.P.A. PIAZZA ALBANIA 10 Rome, IT 00153 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-06 |
| Decision Date | 2011-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E322050900030520 | K102218 | 000 |
| E322050900030510 | K102218 | 000 |
| E322040000790 | K102218 | 000 |
| E322031200160010 | K102218 | 000 |