510(k) · Cleared
ClearedDuraflor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmascience, Inc. · LBH Varnish, Cavity
Cleared on Aug 14, 1996 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Aug 14, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 5 citing it directly.
- This deviceK961893 DuraflorPharmascience, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK030488 FluorilaqPascal Co., Inc. · 2003
- Descendant · cites it directly · 0 of its ownK140349 Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK113146 PCXX VarnishRoss Healthcare, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK102808 MI VarnishGC America, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK090597 Fluorilaq Sodium Fluoride Cavity VarnishPascal Co., Inc. · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K030488FluorilaqPascal Co., Inc. · 2003 · cites it directly2descendants
- K140349Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc. · 2014 · cites it directly0descendants
- K113146PCXX VarnishRoss Healthcare, Inc. · 2012 · cites it directly0descendants
- K102808MI VarnishGC America, Inc. · 2010 · cites it directly0descendants
- K090597Fluorilaq Sodium Fluoride Cavity VarnishPascal Co., Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961893 | Duraflor | Pharmascience, Inc. | 1996 | — |
| +1 | K030488 | Fluorilaq | Pascal Co., Inc. | 2003 | — |
| +1 | K140349 | Starbright 5% Sodium Fluoride Varnish | Nanova Biomaterials, Inc. | 2014 | — |
| +1 | K113146 | PCXX Varnish | Ross Healthcare, Inc. | 2012 | — |
| +1 | K102808 | MI Varnish | GC America, Inc. | 2010 | — |
| +2 | K090597 | Fluorilaq Sodium Fluoride Cavity Varnish | Pascal Co., Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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 12.8 · 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
5 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, K030488 (Pascal Co., Inc., 2003) has gone furthest, with 2 descendants 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/K961893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961893: Duraflor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961893
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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