The following data is part of a premarket notification filed by Cooper Care, Inc. with the FDA for Dentsply G-106 Cavitron Ultrasonic.
| Device ID | K834283 |
| 510k Number | K834283 |
| Device Name: | DENTSPLY G-106 CAVITRON ULTRASONIC |
| Classification | Scaler, Ultrasonic |
| Applicant | COOPER CARE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-25 |
| Decision Date | 1984-03-16 |