The following data is part of a premarket notification filed by Prodent Intl., Inc. with the FDA for Lysta Hygienist Iii Scaler.
| Device ID | K904296 |
| 510k Number | K904296 |
| Device Name: | LYSTA HYGIENIST III SCALER |
| Classification | Scaler, Ultrasonic |
| Applicant | PRODENT INTL., INC. C/O BURDITT, BOWLES & RADZIUS 333 WEST WACKER DR., STE. 2500 Chicago, IL 60606 |
| Contact | Richard O Wood |
| Correspondent | Richard O Wood PRODENT INTL., INC. C/O BURDITT, BOWLES & RADZIUS 333 WEST WACKER DR., STE. 2500 Chicago, IL 60606 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-19 |
| Decision Date | 1990-12-05 |