The following data is part of a premarket notification filed by California Technics, Inc. with the FDA for Ultrasonic Dental Prophylaxis Unit.
| Device ID | K832443 |
| 510k Number | K832443 |
| Device Name: | ULTRASONIC DENTAL PROPHYLAXIS UNIT |
| Classification | Scaler, Ultrasonic |
| Applicant | CALIFORNIA TECHNICS, 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 | 1983-07-25 |
| Decision Date | 1983-09-12 |