The following data is part of a premarket notification filed by Denticator with the FDA for Contra Angle Handpiece Attach. W/prophylaxis Cup.
| Device ID | K881985 |
| 510k Number | K881985 |
| Device Name: | CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUP |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | DENTICATOR 11277 SUNRISE PARK DR. Rancho Cordova, CA 95724 |
| Contact | David L Butler |
| Correspondent | David L Butler DENTICATOR 11277 SUNRISE PARK DR. Rancho Cordova, CA 95724 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-12 |
| Decision Date | 1988-07-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10302732961060 | K881985 | 000 |