510(k) · Cleared
ClearedSonx 35 Ultrasonic Bleaching System; Soniwhite Ultra Sonic, Model Quick White US
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CAO Group, Inc. · EEG Heat Source For Bleaching Teeth
Cleared on Nov 8, 2004 as substantially equivalent to K913724 (Sonex Intl., Corp., 1992) after a 167-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.
- Decided
- Nov 8, 2004
- Review
- 167 days
- Class
- Class I
- Product code
- EEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913724 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK913724 Sonex Ultrasonic Tooth BrushSonex Intl., Corp. · 1992
- This deviceK041392 Sonx 35 Ultrasonic Bleaching System; Soniwhite Ultra Sonic, Model…CAO Group, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK122725 Tanda Pearl, Ultrawyte, PearlSyneron Beauty · 2012
- Descendant · cites it directly · 0 of its ownK070307 Steri -Mate Handpiece Sleeve with Led LightDentsply International, Inc. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913724 | Sonex Ultrasonic Tooth Brush | Sonex Intl., Corp. | 1992 | — |
| 0 (this device) | K041392 | Sonx 35 Ultrasonic Bleaching System; Soniwhite Ultra Sonic, Model Quick White US | CAO Group, Inc. | 2004 | — |
| +1 | K122725 | Tanda Pearl, Ultrawyte, Pearl | Syneron Beauty | 2012 | — |
| +1 | K070307 | Steri -Mate Handpiece Sleeve with Led Light | Dentsply International, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 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? (1)
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 |
|---|---|---|---|
| * | K913724 | Sonex Ultrasonic Tooth BrushSummary page 1…sh, Powered Legally Marketed Predicate Devices for Substantial Equivalence: * Sonex Ultrasonic Toothbrush, Manufactured by Soniexlntl., Corp. 5 10(k) Number: K913 724 Rationale for Substantial Equivalence: The aforementioned devices share similarities for use in the oral cavity for the… | 1992 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K122725 (Syneron Beauty, 2012) has gone furthest, with 0 descendants of its own.
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.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041392: Sonx 35 Ultrasonic Bleaching System; Soniwhite Ultra Sonic, Model Quick White US.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041392
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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