The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Dentsply Cavitron Sps Scaler System.
| Device ID | K970123 |
| 510k Number | K970123 |
| Device Name: | DENTSPLY CAVITRON SPS SCALER SYSTEM |
| Classification | Scaler, Ultrasonic |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Contact | P. Jeffery Lehn |
| Correspondent | P. Jeffery Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-14 |
| Decision Date | 1997-04-11 |
| Summary: | summary |