510(k) · Cleared
ClearedVarnishamerica
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Products Laboratories, Inc. · LBH Varnish, Cavity
Cleared on Feb 4, 2004 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 4, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK040098 VarnishamericaMedical Products Laboratories, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK153334 Oral-B 5% Sodium Fluoride VarnishYoung Dental Manufacturing Co. 1, LLC · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK250714 FluoroDose VarnishCentrix, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK192381 DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing…Scientific Pharmaceuticals · 2020
Most influential descendants
Showing 3 of 3 · See all- K153334Oral-B 5% Sodium Fluoride VarnishYoung Dental Manufacturing Co. 1, LLC · 2016 · cites it directly1descendant
- K250714FluoroDose VarnishCentrix, Inc. · 2025 · cites it directly0descendants
- K192381DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum…Scientific Pharmaceuticals · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040098 | Varnishamerica | Medical Products Laboratories, Inc. | 2004 | — |
| +1 | K153334 | Oral-B 5% Sodium Fluoride Varnish | Young Dental Manufacturing Co. 1, LLC | 2016 | 2 |
| +1 | K250714 | FluoroDose Varnish | Centrix, Inc. | 2025 | — |
| +2 | K192381 | DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing… | Scientific Pharmaceuticals | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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?
- Of its descendants, K153334 (Young Dental Manufacturing Co. 1, LLC, 2016) 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.
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 | — |
https://510kreport.com/device/K040098 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040098: Varnishamerica.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040098
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026