510(k) · Cleared

Cleared

Clinpro Varnish

K151302510(k) TraditionalCleared Sep 18, 2015126-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 Sep 18, 2015 as substantially equivalent to K092141 (3M Espe Dental Products, 2010) and 3 other predicates after a 126-day review. Its family tree reaches back 3 generations to 2005.

Decided: Sep 18, 2015
Review: 126 days
Class: Class II
Product code: LBH
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K051750 (2005). 7 ancestors in all, the oldest K945794 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK051750 Flor-Opal Varnish, Models UP 4500/ UP 4501/ UP 4502Ultradent Products, Inc. · 2005
2 generations backK080249 Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505Ultradent Products, Inc. · 2008
1 generation backK112946 Activ VarnishPulpdent Corporation · 2011
This deviceK151302 Clinpro Varnish3M Company · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K051750	Flor-Opal Varnish, Models UP 4500/ UP 4501/ UP 4502	Ultradent Products, Inc.	2005	—
−2	K080249	Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505	Ultradent Products, Inc.	2008	—
−1	K112946	Activ Varnish	Pulpdent Corporation	2011	—
0 (this device)	K151302	Clinpro Varnish	3M Company	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
2010	3	0

FIG. 1 — Lineage of K151302, 2005–2015Source: 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? (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
*	K092141	Vanish Varnish, 5% Sodium Fluoride White Varnish Summary page 4 … Treating hypersensitive teeth  Treating exposed dentin and root sensitivity Predicate Devices: Vanish™ 5% Sodium Fluoride White Varnish (K092141) Pulpdent® Fluoride Varnish (K093620) Pulpdent® Activ Varnish (K112946) Duraphat® 5% Sodium Fluoride Varnish…	3M Espe Dental Products	2010	—
*	K093620	Pulpdent Fluoride Varnish Summary page 4 … Treating exposed dentin and root sensitivity Predicate Devices: Vanish™ 5% Sodium Fluoride White Varnish (K092141) Pulpdent® Fluoride Varnish (K093620) Pulpdent® Activ Varnish (K112946) Duraphat® 5% Sodium Fluoride Varnish (K945794) Description of De…	Pulpdent Corporation	2010	—
*	K112946	Activ Varnish Summary page 4 …sitivity Predicate Devices: Vanish™ 5% Sodium Fluoride White Varnish (K092141) Pulpdent® Fluoride Varnish (K093620) Pulpdent® Activ Varnish (K112946) Duraphat® 5% Sodium Fluoride Varnish (K945794) Description of Device: Clinpro™ Varnish is a fluoride, cal…	Pulpdent Corporation	2011	—
*	K945794	Duraphat Summary page 4 …Sodium Fluoride White Varnish (K092141) Pulpdent® Fluoride Varnish (K093620) Pulpdent® Activ Varnish (K112946) Duraphat® 5% Sodium Fluoride Varnish (K945794) Description of Device: Clinpro™ Varnish is a fluoride, calcium and phosphate containing coating for use in treat…	Inpharma	1995	—

Also cleared against K092141: 6 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 10 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
None of the 7 ancestors has a recall.
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. 2015, 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?

Clinpro™ Varnish is a fluoride, calcium and phosphate containing coating for use in:

Treating hypersensitive teeth

Treating exposed dentin and root sensitivity

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K151302 · printed Nov 4, 2026

Cite this page

510(k) Report. “K151302: Clinpro Varnish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K151302

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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