510(k) · Cleared
ClearedFluoride Varnish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · LBH Varnish, Cavity
Cleared on Sep 15, 2003 as substantially equivalent to K945794 (Inpharma, 1995) and 1 other predicate after an 84-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Sep 15, 2003
- Review
- 84 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K945794 (1995). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK945794 DuraphatInpharma · 1995
- This deviceK031932 Fluoride VarnishDentsply Intl. · 2003
- Descendant · cites it directly · 0 of its ownK122331 Cavity VarnishDentsply International, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK080814 Voco Profluorid VarnishVoco GmbH · 2008
Most influential descendants
Showing 2 of 2 · See allView 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) | K031932 | Fluoride Varnish | Dentsply Intl. | 2003 | — |
| +1 | K122331 | Cavity Varnish | Dentsply International, Inc. | 2012 | — |
| +1 | K080814 | Voco Profluorid Varnish | Voco GmbH | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K945794 | DuraphatSummary page 1…FLUORIDE VARNISH CLASSIFICATION NAME: Cavity Varnish 872.3260 PRE IICATE DEVICES: Duraphat Fluoride Varnish K945794 Duragard Fluoride Varnish KO0258 1 DEI'ICE DESCRIPTION: FLUORIDE VARNISH coats a prep… | 1995 |
| * | K002581 | Duragard Sodium Fluoride Varnish | 2000 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years.
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
Sealing of dentinal tubules for cavity preparations or on sensitive root surfaces
Cavity liner
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031932 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031932: 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/K031932
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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