The following data is part of a premarket notification filed by Dentsply Intl., Inc. with the FDA for Cavitron Prophy-jet Air Polishing Prophylaxis System.
| Device ID | K130862 |
| 510k Number | K130862 |
| Device Name: | CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM |
| Classification | Scaler, Ultrasonic |
| Applicant | DENTSPLY INTL., INC. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTL., INC. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-28 |
| Decision Date | 2013-07-23 |
| Summary: | summary |