510(k) · Cleared

Cleared

Quicksmile

K052040510(k) TraditionalCleared Oct 18, 200582-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

Cosmetic Dental Materials, Inc. · EEG Heat Source For Bleaching Teeth

Cleared on Oct 18, 2005 as substantially equivalent to K042153 (Dentovations, Inc., 2004) after an 82-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.

Decided: Oct 18, 2005
Review: 82 days
Class: Class I
Product code: EEG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K042153 (2004). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK042153 South Beach Smile Light Whitening SystemDentovations, Inc. · 2004
This deviceK052040 QuicksmileCosmetic Dental Materials, Inc. · 2005
Descendant · cites it directly · 0 of its ownK063704 Britewhite Teeth Whitening System, Model BW1101Beks Incorporated · 2007

Most influential descendants

Showing 1 of 1 · See all

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K052040, 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? (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	Applicant	Decided	Recalls
*	K042153	South Beach Smile Light Whitening System Summary page 1 …IFICATION OF PREDICATE DEVICES The QuickSmile light is substantially equivalent to the South Beach Smile Light Whitening System by Dentovations Inc of Boston MA (510OK #K042153). 9-I Cosmetic Dental Materials QuickSmile Whitening Light Original P…	Dentovations, Inc.	2004	—
*	—	BriteSnifle Named without a submission number			—
*	—	Discus Dental Zoom light Named without a submission number			—

Also cleared against K042153: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063704	Britewhite Teeth Whitening System, Model BW1101	Beks Incorporated	2007	0

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, K063704 (Beks Incorporated, 2007) has gone furthest, with 0 descendants of its own.
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.

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?

The QuickSmile light is intended to emit light in the 600-700 nanometer spectrum to provide a heat source for bleaching teeth.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052040 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052040: Quicksmile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052040

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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