The following data is part of a premarket notification filed by Otres, Llc. with the FDA for Otres Toothbrush Sanitizer Model Tb100w.
| Device ID | K003517 |
| 510k Number | K003517 |
| Device Name: | OTRES TOOTHBRUSH SANITIZER MODEL TB100W |
| Classification | Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile |
| Applicant | OTRES, LLC. 4225 NAPERVILLE RD. SUITE 155 Lisle, IL 60542 |
| Contact | David Buddingh |
| Correspondent | David Buddingh OTRES, LLC. 4225 NAPERVILLE RD. SUITE 155 Lisle, IL 60542 |
| Product Code | MCF |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-14 |
| Decision Date | 2001-06-06 |