The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Premier Ultrasonic Scaler And Inserts.
| Device ID | K010195 |
| 510k Number | K010195 |
| Device Name: | PREMIER ULTRASONIC SCALER AND INSERTS |
| Classification | Scaler, Ultrasonic |
| Applicant | PREMIER DENTAL PRODUCTS CO. 3600 HORIZON DR. P.O. BOX 61574 King Of Prussia, PA 19406 |
| Contact | Willian Frezel |
| Correspondent | Willian Frezel PREMIER DENTAL PRODUCTS CO. 3600 HORIZON DR. P.O. BOX 61574 King Of Prussia, PA 19406 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-22 |
| Decision Date | 2001-04-17 |