The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Model G-61 Ultrasonic Dental Unit.
| Device ID | K791585 |
| 510k Number | K791585 |
| Device Name: | MODEL G-61 ULTRASONIC DENTAL UNIT |
| Classification | Scaler, Ultrasonic |
| Applicant | CAVITRON CORP. 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 | 1979-08-17 |
| Decision Date | 1979-09-19 |