510(k) · Cleared

Cleared

Starbright 5% Sodium Fluoride Varnish

K140349510(k) TraditionalCleared Sep 22, 2014215-day reviewClass II21 CFR 872.3260

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

Nanova Biomaterials, Inc. · LBH Varnish, Cavity

Cleared on Sep 22, 2014 as substantially equivalent to K961893 (Pharmascience, Inc., 1996) and 3 other predicates after a 215-day review. Its family tree reaches back 7 generations to 2001.

Decided: Sep 22, 2014
Review: 215 days
Class: Class II
Product code: LBH
Recalls: None
Predicates: 4

Its longest line of descent runs back 7 generations to K010957 (2001). 15 ancestors in all, the oldest K802926 (1980). No later device cites it as a predicate yet.

By dateBy generation

Root · 7 generations backK010957 Quell DesensitizerJeneric/Pentron, Inc. · 2001
6 generations backK033295 Butler Nucare Root Conditioner with NovaminNovamin Technology, Inc. · 2003
5 generations backK072342 Sultan Tooth Root DesensitizerDentsply International, Inc. · 2007
4 generations backK082198 Durashield PlusDentsply Intl., Inc. · 2008
3 generations backK090519 Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish…3M Company · 2009
2 generations backK100540 Ascent F-Coat Model: 006-00097CAO Group, Inc. · 2010
1 generation backK103160 Nupro Model 13016901CAO Group, Inc. · 2011
This deviceK140349 Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K010957	Quell Desensitizer	Jeneric/Pentron, Inc.	2001	—
−6	K033295	Butler Nucare Root Conditioner with Novamin	Novamin Technology, Inc.	2003	—
−5	K072342	Sultan Tooth Root Desensitizer	Dentsply International, Inc.	2007	—
−4	K082198	Durashield Plus	Dentsply Intl., Inc.	2008	—
−3	K090519	Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5%…	3M Company	2009	—
−2	K100540	Ascent F-Coat Model: 006-00097	CAO Group, Inc.	2010	—
−1	K103160	Nupro Model 13016901	CAO Group, Inc.	2011	—
0 (this device)	K140349	Starbright 5% Sodium Fluoride Varnish	Nanova Biomaterials, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	1	0
1996	1	0
1999	1	0
2005	1	0
2007	1	0
2008	1	0
2010	1	0
2013	1	0

FIG. 1 — Lineage of K140349, 2001–2014Source: 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 LBH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LBH device

#1 K262243 Profisil Freescore 12.8 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (4)

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
*	K961893	Duraflor Summary page 4 …Product Name of Device Company Number Code K961893 Duraflor ® LBH Pharmascience, Inc. K092141 3M Vanish LBH…	Pharmascience, Inc.	1996	—
*	K092141	Vanish Varnish, 5% Sodium Fluoride White Varnish Summary page 4 …Company Number Code K961893 Duraflor ® LBH Pharmascience, Inc. K092141 3M Vanish LBH 3M ESPE K103160 Nupro Model 13016901 LBH Ca…	3M Espe Dental Products	2010	—
*	K103160	Nupro Model 13016901 Summary page 4 …Code K961893 Duraflor ® LBH Pharmascience, Inc. K092141 3M Vanish LBH 3M ESPE K103160 Nupro Model 13016901 LBH Cao Group, Inc. K132109 Enamelast LBH…	CAO Group, Inc.	2011	—
*	K132109	Enamelast Summary page 4 …, Inc. K092141 3M Vanish LBH 3M ESPE K103160 Nupro Model 13016901 LBH Cao Group, Inc. K132109 Enamelast LBH Ultradent Products, Inc 10) Indication for Use: StarBrightTM 5% Sodium…	Ultradent Products Inc. / Oratech, LLC	2013	2

Also cleared against K961893: 4 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 13 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
1 of the 15 ancestors has a recall of any class.
4 other devices also cite its predicate K961893.

How does its category compare?

All LBH devices

LBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · LBH

4in 2025

2007high 8 (2007) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LBH

223in 2025

2007high 256 (2020) · low 69 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LBH

1in 2019

2007high 3 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LBH

7in 2025

2007high 40 (2014) · low 3 (2008)2025

MAUDE reports naming product code LBH, 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	8	69	0	4
2008	6	79	0	3
2009	4	69	0	5
2010	7	107	0	7
2011	3	72	0	8
2012	4	83	0	7
2013	6	160	0	27
2014	6	204	3	40
2015	2	—	0	14
2016	2	—	0	12
2017	0	—	0	11
2018	0	—	2	13
2019	2	—	1	9
2020	5	256	0	10
2021	0	—	0	15
2022	1	—	0	7
2023	3	167	0	8
2024	3	237	0	6
2025	4	223	0	7
2026	5	64	0	—

What is it indicated for?

StarBrightTM 5% Sodium Fluoride Varnish is a fluoride containing preparation for use as a cavity varnish and for the treatment of dentin hypersensitivity.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140349 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140349: Starbright 5% Sodium Fluoride Varnish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140349

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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