The following data is part of a premarket notification filed by Orad, Inc. with the FDA for Orad Toothbrush Cleaner.
| Device ID | K895345 |
| 510k Number | K895345 |
| Device Name: | ORAD TOOTHBRUSH CLEANER |
| Classification | Cleanser, Denture, Over The Counter |
| Applicant | ORAD, INC. 1320 STANDIFORD SUITE 246 Modesto, CA 95350 |
| Contact | Wolfe |
| Correspondent | Wolfe ORAD, INC. 1320 STANDIFORD SUITE 246 Modesto, CA 95350 |
| Product Code | EFT |
| CFR Regulation Number | 872.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-31 |
| Decision Date | 1990-03-07 |