# K042153: South Beach Smile Light Whitening System

- Pathway: 510(k) (Traditional)
- Applicant: Dentovations, Inc.
- Decided: Nov 8, 2004 after 91 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
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BriteSmile: named in the summary without a submission number
- (no number) Dental ZOOM Light: named in the summary without a submission number

## Most influential descendants
- K052040: Quicksmile (2005), 1 descendant of its own
- K122725: Tanda Pearl, Ultrawyte, Pearl (2012), 0 descendants of its own
- K110888: Absolute White Light (2012), 0 descendants of its own
- K063704: Britewhite Teeth Whitening System, Model BW1101 (2007), 0 descendants of its own

## Indications for use
The Dentovations South Beach Smile Light Whitening System is intended for use as a light source for bleaching teeth.

Source page: https://510kreport.com/device/K042153
Methodology: https://510kreport.com/methodology