The following data is part of a premarket notification filed by Agion Technologies, Llc. with the FDA for Zeodyne Toothbrush With Agion Antimicrobial.
| Device ID | K021383 |
| 510k Number | K021383 |
| Device Name: | ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL |
| Classification | Toothbrush, Manual |
| Applicant | AGION TECHNOLOGIES, LLC. 60 AUDUBON RD. Wakefield, MA 01880 |
| Contact | Paul C Ford |
| Correspondent | Paul C Ford AGION TECHNOLOGIES, LLC. 60 AUDUBON RD. Wakefield, MA 01880 |
| Product Code | EFW |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-02 |
| Decision Date | 2002-07-17 |
| Summary: | summary |