The following data is part of a premarket notification filed by Dental Ventures Of America, Inc. with the FDA for Piezomatic Ultrasonic Scaler (system S).
| Device ID | K780808 |
| 510k Number | K780808 |
| Device Name: | PIEZOMATIC ULTRASONIC SCALER (SYSTEM S) |
| Classification | Scaler, Ultrasonic |
| Applicant | DENTAL VENTURES OF AMERICA, 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 | 1978-05-18 |
| Decision Date | 1978-06-22 |