The following data is part of a premarket notification filed by Mectron Spa with the FDA for Multipiezo Pro, Multipiezo.
| Device ID | K140965 |
| 510k Number | K140965 |
| Device Name: | MULTIPIEZO PRO, MULTIPIEZO |
| Classification | Scaler, Ultrasonic |
| Applicant | MECTRON SPA PIAZZA ALBANIA, 10 Rome, IT 00153 |
| Contact | Roger Gray |
| Correspondent | Roger Gray MECTRON SPA 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 | 2014-04-15 |
| Decision Date | 2014-08-20 |
| Summary: | summary |