The following data is part of a premarket notification filed by Pro-dentec with the FDA for Rota-dent Tooth Cleaner.
| Device ID | K880589 |
| 510k Number | K880589 |
| Device Name: | ROTA-DENT TOOTH CLEANER |
| Classification | Toothbrush, Powered |
| Applicant | PRO-DENTEC 333 WEST WACKER DR. SUITE 1900 Chicago, IL 60606 |
| Contact | Thomas J Muldoon |
| Correspondent | Thomas J Muldoon PRO-DENTEC 333 WEST WACKER DR. SUITE 1900 Chicago, IL 60606 |
| Product Code | JEQ |
| CFR Regulation Number | 872.6865 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-11 |
| Decision Date | 1988-05-11 |