510(k) · Cleared
ClearedVanish Varnish, 5% Sodium Fluoride White Varnish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe Dental Products · LBH Varnish, Cavity
Cleared on Mar 10, 2010 after a 238-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Mar 10, 2010
- Review
- 238 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 7 citing it directly.
- This deviceK092141 Vanish Varnish, 5% Sodium Fluoride White Varnish3M Espe Dental Products · 2010
- Descendant · cites it directly · 1 of its ownK131376 Smartcoat 2.5% Naf VarnishElevate Oral Care · 2013
- Descendant · 2 generations on · 0 of its ownK250714 FluoroDose VarnishCentrix, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK230333 Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride…Kettenbach GmbH & Co. KG · 2023
- Descendant · cites it directly · 0 of its ownK231338 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment3M Espe Dental Products · 2023
- Descendant · cites it directly · 0 of its ownK182917 FluoroCalBisco, Inc. · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K131376Smartcoat 2.5% Naf VarnishElevate Oral Care · 2013 · cites it directly1descendant
- K250714FluoroDose VarnishCentrix, Inc. · 2025 · 2 generations on0descendants
- K230333Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint…Kettenbach GmbH & Co. KG · 2023 · cites it directly0descendants
- K2313383M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment3M Espe Dental Products · 2023 · cites it directly0descendants
- K182917FluoroCalBisco, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092141 | Vanish Varnish, 5% Sodium Fluoride White Varnish | 3M Espe Dental Products | 2010 | — |
| +1 | K131376 | Smartcoat 2.5% Naf Varnish | Elevate Oral Care | 2013 | — |
| +2 | K250714 | FluoroDose Varnish | Centrix, Inc. | 2025 | — |
| +1 | K230333 | Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal… | Kettenbach GmbH & Co. KG | 2023 | — |
| +1 | K231338 | 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment | 3M Espe Dental Products | 2023 | — |
| +1 | K182917 | FluoroCal | Bisco, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | — | 3M™ ESPE™ Vanish™ Varnish Named without a submission number | |
| * | — | Enamel Pro® Varnish Named without a submission number |
What descends from it? (8)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131376 | Smartcoat 2.5% Naf Varnish | 2013 | 1 |
| K230333 | Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint… | 2023 | 0 |
| K231338 | 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment | 2023 | 0 |
| K182917 | FluoroCal | 2019 | 0 |
| K151302 | Clinpro Varnish | 2015 | 0 |
| K140349 | Starbright 5% Sodium Fluoride Varnish | 2014 | 0 |
| K102808 | MI Varnish | 2010 | 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?
- Of its descendants, K131376 (Elevate Oral Care, 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LBH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LBH
223in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LBH
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBH
7in 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/K092141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092141: Vanish Varnish, 5% Sodium Fluoride White Varnish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092141
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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