K023662 is an FDA 510(k) clearance for the PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER. This device is classified as a Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile (Class I - General Controls, product code MCF).
Submitted by Hwadong International Company , Ltd. (Ft. Lauderdale, US). The FDA issued a Cleared decision on May 28, 2003, 209 days after receiving the submission on October 31, 2002.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6855.
| 510(k) Number | K023662 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2002 |
| Decision Date | May 28, 2003 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MCF — Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6855 |