The following data is part of a premarket notification filed by Coronet Group North America, Llc. with the FDA for Medoral Hygienic Toothbrush With Dentosan Filaments.
| Device ID | K020776 |
| 510k Number | K020776 |
| Device Name: | MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS |
| Classification | Toothbrush, Manual |
| Applicant | CORONET GROUP NORTH AMERICA, LLC. 181 DIXION RD. Queensbury,, NY 12804 |
| Contact | Thomas E Ferari |
| Correspondent | Thomas E Ferari CORONET GROUP NORTH AMERICA, LLC. 181 DIXION RD. Queensbury,, NY 12804 |
| Product Code | EFW |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-11 |
| Decision Date | 2002-06-03 |
| Summary: | summary |