510(k) · Cleared

Cleared

Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5% Fluoride Varnish, Model 12247

K090519510(k) SpecialCleared Apr 15, 200948-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

3M Company · LBH Varnish, Cavity

Cleared on Apr 15, 2009 as substantially equivalent to K982915 (Scientific Pharmaceuticals, Inc., 1999) and 2 other predicates after a 48-day review. Its family tree reaches back 4 generations to 2001. 3 later devices descend from it.

Decided: Apr 15, 2009
Review: 48 days
Class: Class II
Product code: LBH
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K010957 (2001). 7 ancestors in all, the oldest K802926 (1980). 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK010957 Quell DesensitizerJeneric/Pentron, Inc. · 2001
3 generations backK033295 Butler Nucare Root Conditioner with NovaminNovamin Technology, Inc. · 2003
2 generations backK072342 Sultan Tooth Root DesensitizerDentsply International, Inc. · 2007
1 generation backK082198 Durashield PlusDentsply Intl., Inc. · 2008
This deviceK090519 Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish…3M Company · 2009
Descendant · cites it directly · 2 of its ownK100540 Ascent F-Coat Model: 006-00097CAO Group, Inc. · 2010
Descendant · 2 generations on · 1 of its ownK103160 Nupro Model 13016901CAO Group, Inc. · 2011
Descendant · 3 generations on · 0 of its ownK140349 Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc. · 2014

Most influential descendants

Showing 3 of 3 · See all

K100540Ascent F-Coat Model: 006-00097CAO Group, Inc. · 2010 · cites it directly2descendants
K103160Nupro Model 13016901CAO Group, Inc. · 2011 · 2 generations on1descendant
K140349Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc. · 2014 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K010957	Quell Desensitizer	Jeneric/Pentron, Inc.	2001	—
−3	K033295	Butler Nucare Root Conditioner with Novamin	Novamin Technology, Inc.	2003	—
−2	K072342	Sultan Tooth Root Desensitizer	Dentsply International, Inc.	2007	—
−1	K082198	Durashield Plus	Dentsply Intl., Inc.	2008	—
0 (this device)	K090519	Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5%…	3M Company	2009	—
+1	K100540	Ascent F-Coat Model: 006-00097	CAO Group, Inc.	2010	—
+2	K103160	Nupro Model 13016901	CAO Group, Inc.	2011	—
+3	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
1999	1	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	1	0
2014	1	0

FIG. 1 — Lineage of K090519, 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? (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
*	K982915	Sci-Pharm DFV Varnish Summary page 1 …avity Varnish Predicate Devices Device 510(k) Sci-Pharm DFV Varnish K982915 Universal Cavity Varnish K802926 DuraShield Plus…	Scientific Pharmaceuticals, Inc.	1999	—
*	K802926	Sci-Pharm Universal Cavity Varnish Summary page 1 …510(k) Sci-Pharm DFV Varnish K982915 Universal Cavity Varnish K802926 DuraShield Plus K0821 98 Description and Technology Equivalence Vanish TM Varni…	Scientific Pharmaceuticals, Inc.	1980	—
*	K082198	Durashield Plus Summary page 1 …K982915 Universal Cavity Varnish K802926 DuraShield Plus K0821 98 Description and Technology Equivalence Vanish TM Varnish, 5% Sodium Fluoride Varnish is classified as Cavity Varnish (21 C.F.R§…	Dentsply Intl., Inc.	2008	—

Also cleared against K982915: 3 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K100540	Ascent F-Coat Model: 006-00097	CAO Group, Inc.	2010	2

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 8 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
None of the 7 ancestors has a recall.
Of its descendants, K100540 (CAO Group, Inc., 2010) has gone furthest, with 2 descendants of its own.
3 other devices also cite its predicate K982915.

How does its category compare?

All LBH devices

LBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?

Treatment of hypersensitive teeth

use on exposed dentin and root sensitivity

under temporary restoratives and cements where post-operative sensitivity is of

concern.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090519 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090519: Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5% Fluoride Varnish, Model 12247.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090519

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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