510(k) · Cleared
ClearedSouth Beach Smile Light Whitening System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentovations, Inc. · EEG Heat Source For Bleaching Teeth
Cleared on Nov 8, 2004 after a 91-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Nov 8, 2004
- Review
- 91 days
- Class
- Class I
- Product code
- EEG
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK042153 South Beach Smile Light Whitening SystemDentovations, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK052040 QuicksmileCosmetic Dental Materials, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK122725 Tanda Pearl, Ultrawyte, PearlSyneron Beauty · 2012
- Descendant · cites it directly · 0 of its ownK110888 Absolute White LightDr. Fresh, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK063704 Britewhite Teeth Whitening System, Model BW1101Beks Incorporated · 2007
Most influential descendants
Showing 4 of 4 · See all- K052040QuicksmileCosmetic Dental Materials, Inc. · 2005 · cites it directly1descendant
- K122725Tanda Pearl, Ultrawyte, PearlSyneron Beauty · 2012 · cites it directly0descendants
- K110888Absolute White LightDr. Fresh, Inc. · 2012 · cites it directly0descendants
- K063704Britewhite Teeth Whitening System, Model BW1101Beks Incorporated · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042153 | South Beach Smile Light Whitening System | Dentovations, Inc. | 2004 | — |
| +1 | K052040 | Quicksmile | Cosmetic Dental Materials, Inc. | 2005 | — |
| +1 | K122725 | Tanda Pearl, Ultrawyte, Pearl | Syneron Beauty | 2012 | — |
| +1 | K110888 | Absolute White Light | Dr. Fresh, Inc. | 2012 | — |
| +1 | K063704 | Britewhite Teeth Whitening System, Model BW1101 | Beks Incorporated | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | — | BriteSmile Named without a submission number | |
| * | — | Dental ZOOM Light Named without a submission number |
What descends from it? (4)
4 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?
- Of its descendants, K052040 (Cosmetic Dental Materials, Inc., 2005) has gone furthest, with 1 descendant 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 Dentovations South Beach Smile Light Whitening System is intended for use
as a light source for bleaching teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042153: South Beach Smile Light Whitening System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042153
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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