K003517 is an FDA 510(k) clearance for the OTRES TOOTHBRUSH SANITIZER MODEL TB100W. This device is classified as a Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile (Class I - General Controls, product code MCF).
Submitted by Otres, LLC (Lisle, US). The FDA issued a Cleared decision on June 6, 2001, 204 days after receiving the submission on November 14, 2000.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6855.
| 510(k) Number | K003517 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2000 |
| Decision Date | June 06, 2001 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | MCF — Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6855 |