The following data is part of a premarket notification filed by Dentsply International, Inc. with the FDA for Cavitron Touch Ultrasonic Scaling System.
| Device ID | K150535 |
| 510k Number | K150535 |
| Device Name: | Cavitron Touch Ultrasonic Scaling System |
| Classification | Scaler, Ultrasonic |
| Applicant | DENTSPLY INTERNATIONAL, INC. 221 WEST PHILADELPHIA ST. SUITE 60W York, PA 17401 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL, INC. 221 WEST PHILADELPHIA ST. SUITE 60W York, PA 17401 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-03 |
| Decision Date | 2015-06-16 |
| Summary: | summary |