# K063704: Britewhite Teeth Whitening System, Model BW1101

- Pathway: 510(k) (Traditional)
- Applicant: Beks Incorporated
- Decided: Feb 20, 2007 after 69 days
- Product code: EEG (Heat Source For Bleaching Teeth)
- Device class: 1
- Regulation: 21 CFR 872.6475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K042153 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042153: South Beach Smile Light Whitening System, Dentovations, Inc. (2004) Summary page 1.
- K052040: Quicksmile, Cosmetic Dental Materials, Inc. (2005) Summary page 1.

## Indications for use
BriteWhite Teeth Whitening System is intended to emit light in the 400 nanometer spectrum to provide a light source for the bleaching of teeth.

Source page: https://510kreport.com/device/K063704
Methodology: https://510kreport.com/methodology