K110888 is an FDA 510(k) clearance for the ABSOLUTE WHITE LIGHT. This device is classified as a Heat Source For Bleaching Teeth (Class I - General Controls, product code EEG).
Submitted by Dr. Fresh, Inc. (Houston, US). The FDA issued a Cleared decision on January 12, 2012, 288 days after receiving the submission on March 30, 2011.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6475.
| 510(k) Number | K110888 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2011 |
| Decision Date | January 12, 2012 |
| Days to Decision | 288 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 |