The following data is part of a premarket notification filed by Denticator Intl., Inc. with the FDA for Disposable Prophy Handpiece.
| Device ID | K954012 |
| 510k Number | K954012 |
| Device Name: | DISPOSABLE PROPHY HANDPIECE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | DENTICATOR INTL., INC. 11330 SUNRISE PARK DR., #A Rancho Cordova, CA 95742 |
| Contact | Leslie Anderson |
| Correspondent | Leslie Anderson DENTICATOR INTL., INC. 11330 SUNRISE PARK DR., #A Rancho Cordova, CA 95742 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-25 |
| Decision Date | 1995-11-08 |