The following data is part of a premarket notification filed by Action Hygiene Products, Inc. with the FDA for Odonto Toothbrush.
| Device ID | K852691 |
| 510k Number | K852691 |
| Device Name: | ODONTO TOOTHBRUSH |
| Classification | Toothbrush, Manual |
| Applicant | ACTION HYGIENE PRODUCTS, INC. 4000 CHESSWOOD DR. DOWNSVIEW, ONT. Canada M3j 2b9, CA |
| Contact | Myers |
| Correspondent | Myers ACTION HYGIENE PRODUCTS, INC. 4000 CHESSWOOD DR. DOWNSVIEW, ONT. Canada M3j 2b9, CA |
| Product Code | EFW |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-26 |
| Decision Date | 1985-09-27 |