510(k) · Cleared
ClearedVoco Profluorid Varnish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Voco GmbH · LBH Varnish, Cavity
Cleared on Jul 24, 2008 as substantially equivalent to K945794 (Inpharma, 1995) and 2 other predicates after a 122-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jul 24, 2008
- Review
- 122 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K945794 (1995). 4 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 | K031932 | Fluoride Varnish | Dentsply Intl. | 2003 | — |
| 0 (this device) | K080814 | Voco Profluorid Varnish | Voco GmbH | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 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? (3)
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…VOCO Profiuorid Varnish Classification name: Varnish, Cavity (872.3260) Predicate device: Duraphat K945794 Fluoride Varnish K031932 Device description: VOCO Profluorid Varnish is a… | 1995 |
| * | K031932 | Fluoride VarnishSummary page 1…Varnish, Cavity (872.3260) Predicate device: Duraphat K945794 Fluoride Varnish K031932 Device description: VOCO Profluorid Varnish is a fluoride containing dental varnish for application… | 2003 |
| * | K961893 | DuraflorSummary page 1…Technological characteristics: All of the components of VOCO Profluorid Varnish are found in the legally marketed devices K9457'94 (Duraphat), K031932 (Fluoride K961893 (Duraflor Cavity Varnish) with the? exception of ethyl cellulose Varnish) and… | 1996 |
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 13 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- None of the 4 ancestors has a recall.
- 7 other devices also cite its predicate K945794.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
VOCO Profluorid Varnish is intended for use as
- Treatment of hypersensitive teeth,
- Sealing the dentinal tubules for cavity preparations or on sensitive root surfaces
- Cavity liner under amalgam restorations
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080814: Voco Profluorid Varnish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080814
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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