510(k) · Cleared
ClearedActiv Varnish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulpdent Corporation · LBH Varnish, Cavity
Cleared on Dec 9, 2011 as substantially equivalent to K093620 (Pulpdent Corporation, 2010) and 3 other predicates after a 66-day review. Its family tree reaches back 2 generations to 2005. 1 later device descends from it.
- Decided
- Dec 9, 2011
- Review
- 66 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K051750 (2005). 5 ancestors in all, the oldest K945794 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK051750 Flor-Opal Varnish, Models UP 4500/ UP 4501/ UP 4502Ultradent Products, Inc. · 2005
- 1 generation backK080249 Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505Ultradent Products, Inc. · 2008
- This deviceK112946 Activ VarnishPulpdent Corporation · 2011
- Descendant · cites it directly · 0 of its ownK151302 Clinpro Varnish3M Company · 2015
Most influential descendants
Showing 1 of 1 · See all- K151302Clinpro Varnish3M Company · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051750 | Flor-Opal Varnish, Models UP 4500/ UP 4501/ UP 4502 | Ultradent Products, Inc. | 2005 | — |
| −1 | K080249 | Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505 | Ultradent Products, Inc. | 2008 | — |
| 0 (this device) | K112946 | Activ Varnish | Pulpdent Corporation | 2011 | — |
| +1 | K151302 | Clinpro Varnish | 3M Company | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K093620 | Pulpdent Fluoride VarnishSummary page 1…ride, Calcium and Phosphate salts, Flavorant. Pulpdent Fluoride Varnish K(093620 Resin-based fluoride To treat tooth Rosin, Ethyl lactate FCC, Sodium… | 2010 |
| * | K080249 | Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505Summary page 1…Ethyl lactate FCC, Sodium varnish hypersensitivity fluoride, Ftavorant Ultradent K(080249 5%sodium fluoride ina To treat tooth Natural resin, Alcohol, Xytitol Flor-Opal Varnish White… | 2008 |
| Kept off the family tree | K080741 | FDA’s K080741 is Mega Soft Reusable Patient Return Electrode Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
| * | K945794 | DuraphatSummary page 1…Sodium fluoride, Thickener, Flavor and Color Colgate Buraphat K(945794 Rosin-based fluoride To treat tooth Rosin, Ethyl alcohol, Sodium… | 1995 |
| * | K101104 | Remin ProSummary page 1…l alcohol, Sodium varnish hypersensitivity, fluoride, Water, Flavorant Voco RerninPro K(101104 Hydroxyapatite and Prevention and Calcium phosphate, Sodium… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151302 | Clinpro Varnish | 2015 | 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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K151302 (3M Company, 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K093620.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Activ Varnish is a resin-based varnish, containing 17% Xylitol and less than 20% ethanol, that is applied to enamel or dentin for professional treatment of dental hypersensitivity. Activ Varnish treats hypersensitivity by releasing fluoride, calcium and phosphorus ions that precipitate on and, thereby, occlude dentinal tubules and fill superficial, non-carious enamel lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112946: Activ Varnish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112946
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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