510(k) · Cleared
ClearedTanda Pearl, Ultrawyte, Pearl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syneron Beauty · EEG Heat Source For Bleaching Teeth
Cleared on Nov 27, 2012 as substantially equivalent to K042153 (Dentovations, Inc., 2004) and 1 other predicate after an 83-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Nov 27, 2012
- Review
- 83 days
- Class
- Class I
- Product code
- EEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K913724 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913724 | Sonex Ultrasonic Tooth Brush | Sonex Intl., Corp. | 1992 | — |
| −1 | K041392 | Sonx 35 Ultrasonic Bleaching System; Soniwhite Ultra Sonic, Model Quick White US | CAO Group, Inc. | 2004 | — |
| 0 (this device) | K122725 | Tanda Pearl, Ultrawyte, Pearl | Syneron Beauty | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EEG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042153 | South Beach Smile Light Whitening SystemSummary page 1…Name EEG Predicate Devices Glo Science LLC's Glo Brilliant Whitening Device (510(k) exempt) Dentovations Inc.'s South Beach Smile Light Whitening System (K042153) CAO Group Inc.'s SoniC 35 Ultrasonic Bleaching System (K041392) Intended Use / Indications for Use The Tanda. Pe… | 2004 |
| * | K041392 | Sonx 35 Ultrasonic Bleaching System; Soniwhite Ultra Sonic, Model Quick White USSummary page 1…tening Device (510(k) exempt) Dentovations Inc.'s South Beach Smile Light Whitening System (K042153) CAO Group Inc.'s SoniC 35 Ultrasonic Bleaching System (K041392) Intended Use / Indications for Use The Tanda. Pearl is an over-the-counter device intended for teeth bleaching. The Tan… | 2004 |
| * | — | Glo Science LLC's Glo Brilliant Whitening Device Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 11.9 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K042153.
How does its category compare?
All EEG devicesEEG Heat Source For Bleaching Teeth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · EEG
2in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · EEG
Too few EEG 510(k)s in any year since 2007 to give a median.
Recalls per year · EEG
No recall names EEG since 2007.
Adverse event reports per year · EEG
7in 2025
MAUDE reports naming product code EEG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122725: Tanda Pearl, Ultrawyte, Pearl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122725
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026