The following data is part of a premarket notification filed by Ultrasonic Services Inc. with the FDA for Usi Dental Scaler, 25xxx Series.
| Device ID | K062791 |
| 510k Number | K062791 |
| Device Name: | USI DENTAL SCALER, 25XXX SERIES |
| Classification | Scaler, Ultrasonic |
| Applicant | ULTRASONIC SERVICES INC. 7126 MULLINS DRIVE Houston, TX 77081 |
| Contact | James Feine |
| Correspondent | James Feine ULTRASONIC SERVICES INC. 7126 MULLINS DRIVE Houston, TX 77081 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-18 |
| Decision Date | 2006-12-11 |