510(k) · Cleared

Cleared

Smartcoat 2.5% Naf Varnish

K131376510(k) TraditionalCleared Aug 27, 2013105-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

Cleared on Aug 27, 2013 as substantially equivalent to K092141 (3M Espe Dental Products, 2010) and 2 other predicates after a 105-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Aug 27, 2013
Review: 105 days
Class: Class II
Product code: LBH
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K945794 (1995). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK945794 DuraphatInpharma · 1995
This deviceK131376 Smartcoat 2.5% Naf VarnishElevate Oral Care · 2013
Descendant · cites it directly · 0 of its ownK250714 FluoroDose VarnishCentrix, Inc. · 2025

Most influential descendants

Showing 1 of 1 · See all

K250714FluoroDose VarnishCentrix, Inc. · 2025 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945794	Duraphat	Inpharma	1995	—
0 (this device)	K131376	Smartcoat 2.5% Naf Varnish	Elevate Oral Care	2013	—
+1	K250714	FluoroDose Varnish	Centrix, Inc.	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	1	0

FIG. 1 — Lineage of K131376, 1995–2025Source: 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 12.9 · 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
*	K092141	Vanish Varnish, 5% Sodium Fluoride White Varnish Summary page 1 …vity Varnish Predicate Devices Device 510(k) Vanish 5% NaF Varnish K092141 VivaSens K030922 Duraphat 5%NaF Varnish K945794 Desc…	3M Espe Dental Products	2010	—
*	K030922	Vivasens Summary page 1 …510(k) Vanish 5% NaF Varnish K092141 VivaSens K030922 Duraphat 5%NaF Varnish K945794 Description SmartCoat 2.5% NaF Varnish is classified as a Cavity…	Ivoclar Vivadent, Inc.	2003	—
*	K945794	Duraphat Summary page 1 …sh 5% NaF Varnish K092141 VivaSens K030922 Duraphat 5%NaF Varnish K945794 Description SmartCoat 2.5% NaF Varnish is classified as a Cavity Varnish (21 CFR 872.3260) because it is a device that provides…	Inpharma	1995	—

Also cleared against K092141: 6 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
K250714	FluoroDose Varnish	Centrix, Inc.	2025	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?

None of the 3 ancestors has a recall.
Of its descendants, K250714 (Centrix, Inc., 2025) has gone furthest, with 0 descendants of its own.
6 other devices also cite its predicate K092141.

How does its category compare?

All LBH devices

LBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?

SmartCoat 2.5% NaF Varnish is intended for use on sensitive teeth, over exposed dentin and root surface sensitivity, and under temporary restorations or cements where post operative sensitivity is of concern.

Rapid Desensitizer

Provides rapid relief from sensitive teeth due to hypersensitivty

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K131376 · printed Nov 5, 2026

Cite this page

510(k) Report. “K131376: Smartcoat 2.5% Naf Varnish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131376

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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