The following data is part of a premarket notification filed by Dr. Fresh, Inc. with the FDA for Absolute White Light.
| Device ID | K110888 |
| 510k Number | K110888 |
| Device Name: | ABSOLUTE WHITE LIGHT |
| Classification | Heat Source For Bleaching Teeth |
| Applicant | DR. FRESH, INC. 12101 CULLEN BLVD Houston, TX 77047 -1131 |
| Contact | M. Joyce Heinrich |
| Correspondent | M. Joyce Heinrich DR. FRESH, INC. 12101 CULLEN BLVD Houston, TX 77047 -1131 |
| Product Code | EEG |
| CFR Regulation Number | 872.6475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-30 |
| Decision Date | 2012-01-12 |
| Summary: | summary |