# K041392: Sonx 35 Ultrasonic Bleaching System; Soniwhite Ultra Sonic, Model Quick White US

- Pathway: 510(k) (Traditional)
- Applicant: CAO Group, Inc.
- Decided: Nov 8, 2004 after 167 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: 1 generation back to K913724 (1992). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913724: Sonex Ultrasonic Tooth Brush, Sonex Intl., Corp. (1992) Summary page 1.

## Most influential descendants
- K122725: Tanda Pearl, Ultrawyte, Pearl (2012), 0 descendants of its own
- K070307: Steri -Mate Handpiece Sleeve with Led Light (2007), 0 descendants of its own

## Indications for use
The SonX 35 Ultrasonic Bleaching System is used to accelerate the action of a tooth bleaching medium by introducing energy into said medium in the form of ultrasonic vibrational impulses at a frequency cycled between 25000 and 30000 hertz, improving the appearance of teeth.

Source page: https://510kreport.com/device/K041392
Methodology: https://510kreport.com/methodology