K042153 is an FDA 510(k) clearance for the SOUTH BEACH SMILE LIGHT WHITENING SYSTEM. This device is classified as a Heat Source For Bleaching Teeth (Class I - General Controls, product code EEG).
Submitted by Dentovations, Inc. (Houston, US). The FDA issued a Cleared decision on November 8, 2004, 91 days after receiving the submission on August 9, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6475.
| 510(k) Number | K042153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2004 |
| Decision Date | November 08, 2004 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EEG — Heat Source For Bleaching Teeth |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6475 |