510(k) · Cleared

Cleared

Britewhite Teeth Whitening System, Model BW1101

K063704510(k) TraditionalCleared Feb 20, 200769-day reviewClass I21 CFR 872.6475

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Beks Incorporated · EEG Heat Source For Bleaching Teeth

Cleared on Feb 20, 2007 as substantially equivalent to K042153 (Dentovations, Inc., 2004) and 1 other predicate after a 69-day review. Its family tree reaches back 2 generations to 2004.

Decided: Feb 20, 2007
Review: 69 days
Class: Class I
Product code: EEG
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K042153 (2004). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK042153 South Beach Smile Light Whitening SystemDentovations, Inc. · 2004
1 generation backK052040 QuicksmileCosmetic Dental Materials, Inc. · 2005
This deviceK063704 Britewhite Teeth Whitening System, Model BW1101Beks Incorporated · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K042153	South Beach Smile Light Whitening System	Dentovations, Inc.	2004	—
−1	K052040	Quicksmile	Cosmetic Dental Materials, Inc.	2005	—
0 (this device)	K063704	Britewhite Teeth Whitening System, Model BW1101	Beks Incorporated	2007	—

FIG. 1 — Lineage of K063704, 2004–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K042153	South Beach Smile Light Whitening System Summary page 1 …valent in respect to the intended use, design and method of operation to numerous cleared devices, including; the South Beach Smile Light Whitening System (K(042153), QuickSmile (K052040). 4. Device Description The BriteWhite Teeth Whitening System device that utilizes Light Emittin…	Dentovations, Inc.	2004	—
*	K052040	Quicksmile Summary page 1 …the intended use, design and method of operation to numerous cleared devices, including; the South Beach Smile Light Whitening System (K(042153), QuickSmile (K052040). 4. Device Description The BriteWhite Teeth Whitening System device that utilizes Light Emitting Diodes to provide a…	Cosmetic Dental Materials, Inc.	2005	—

Also cleared against K042153: 3 other devices →

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 3 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K042153.

How does its category compare?

All EEG devices

EEG Heat Source For Bleaching Teeth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · EEG

2in 2012

2007high 2 (2012) · low 0 (2008)2026

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

2007high 10 (2017) · low 0 (2009)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	MAUDE reports
2007	1	—	3
2008	0	—	3
2009	0	—	0
2010	0	—	3
2011	0	—	7
2012	2	—	2
2013	0	—	2
2014	0	—	7
2015	0	—	1
2016	0	—	8
2017	0	—	10
2018	0	—	6
2019	0	—	3
2020	0	—	6
2021	0	—	6
2022	0	—	4
2023	0	—	0
2024	0	—	1
2025	0	—	7
2026	0	—	—

What is it indicated for?

BriteWhite Teeth Whitening System is intended to emit light in the 400 nanometer

spectrum to provide a light source for the bleaching of teeth.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063704 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063704: Britewhite Teeth Whitening System, Model BW1101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063704

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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