# K122725: Tanda Pearl, Ultrawyte, Pearl

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Beauty
- Decided: Nov 27, 2012 after 83 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 K913724 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.
- K041392: Sonx 35 Ultrasonic Bleaching System; Soniwhite Ultra Sonic, Model Quick White US, CAO Group, Inc. (2004) Summary page 1.
- (no number) Glo Science LLC's Glo Brilliant Whitening Device: named in the summary without a submission number

## Indications for use
The Tanda Pearl is an over-the-counter device intended for teeth bleaching. The Tanda. Pearl uses low electrical current to accelerate the action of the bleaching agent to improve the whitened appearance of teeth.

Source page: https://510kreport.com/device/K122725
Methodology: https://510kreport.com/methodology