The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Cavitron Rf Ultrasonic Scaler System With Sterimate Handpiece, Model G-131.
| Device ID | K052334 |
| 510k Number | K052334 |
| Device Name: | CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 |
| Classification | Scaler, Ultrasonic |
| Applicant | DENTSPLY INTL. 221 WEST PHILADELPHIA STREET York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTL. 221 WEST PHILADELPHIA STREET York, PA 17404 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-26 |
| Decision Date | 2005-09-02 |
| Summary: | summary |