510(k) · Cleared
ClearedFluoroDose Varnish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centrix, Inc. · LBH Varnish, Cavity
Cleared on Nov 21, 2025 as substantially equivalent to K040098 (Medical Products Laboratories, Inc., 2004) and 1 other predicate after a 256-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Nov 21, 2025
- Review
- 256 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945794 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945794 | Duraphat | Inpharma | 1995 | — |
| −1 | K131376 | Smartcoat 2.5% Naf Varnish | Elevate Oral Care | 2013 | — |
| 0 (this device) | K250714 | FluoroDose Varnish | Centrix, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K040098 | VarnishamericaSummary page 5…BH Classification: Class 2 Medical Specialty (Panel): Dental 3. PREDICATE DEVICES • Primary Predicate: Varnish America (Young Dental / MPL) K040098 • Secondary Predicate: Elevate SmartCoat 2.5% (FluoriMax) K131376 • Reference Predicate: 3M Clinpro 2.1% K231338 === Page… | 2004 |
| * | K131376 | Smartcoat 2.5% Naf VarnishSummary page 5…Dental 3. PREDICATE DEVICES • Primary Predicate: Varnish America (Young Dental / MPL) K040098 • Secondary Predicate: Elevate SmartCoat 2.5% (FluoriMax) K131376 • Reference Predicate: 3M Clinpro 2.1% K231338 4. DEVICE DESCRIPTION The FluoroDose Varnish is a fluoride… | 2013 |
| † | K231338 | 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment | 2023 |
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 30 years and passes through 3 companies; a new generation was cleared every 18.1 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K040098.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 dental hypersensitivity and reduction of post-operative sensitivity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250714: FluoroDose Varnish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250714
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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