The following data is part of a premarket notification filed by Dentalez Group with the FDA for Rotory Scaler Swivel Improvement Feature, Titan Sw.
| Device ID | K881253 |
| 510k Number | K881253 |
| Device Name: | ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW |
| Classification | Scaler, Ultrasonic |
| Applicant | DENTALEZ GROUP 1818 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Contact | Donald I Gonser |
| Correspondent | Donald I Gonser DENTALEZ GROUP 1818 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-23 |
| Decision Date | 1988-04-21 |