510(k) · Cleared
ClearedSci-Pharm DFV Varnish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scientific Pharmaceuticals, Inc. · LBH Varnish, Cavity
Cleared on Feb 12, 1999 after a 177-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Feb 12, 1999
- Review
- 177 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK982915 Sci-Pharm DFV VarnishScientific Pharmaceuticals, Inc. · 1999
- Descendant · cites it directly · 4 of its ownK082198 Durashield PlusDentsply Intl., Inc. · 2008
- Descendant · cites it directly · 3 of its ownK090519 Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish…3M Company · 2009
- Descendant · 2 generations on · 2 of its ownK100540 Ascent F-Coat Model: 006-00097CAO Group, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK030488 FluorilaqPascal Co., Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK103160 Nupro Model 13016901CAO Group, Inc. · 2011
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K082198Durashield PlusDentsply Intl., Inc. · 2008 · cites it directly4descendants
- K090519Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5% Fluoride…3M Company · 2009 · cites it directly3descendants
- K100540Ascent F-Coat Model: 006-00097CAO Group, Inc. · 2010 · 2 generations on2descendants
- K030488FluorilaqPascal Co., Inc. · 2003 · cites it directly2descendants
- K103160Nupro Model 13016901CAO Group, Inc. · 2011 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982915 | Sci-Pharm DFV Varnish | Scientific Pharmaceuticals, Inc. | 1999 | — |
| +1 | K082198 | Durashield Plus | Dentsply Intl., Inc. | 2008 | — |
| +1 | K090519 | Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5%… | 3M Company | 2009 | — |
| +2 | K100540 | Ascent F-Coat Model: 006-00097 | CAO Group, Inc. | 2010 | — |
| +1 | K030488 | Fluorilaq | Pascal Co., Inc. | 2003 | — |
| +2 | K103160 | Nupro Model 13016901 | CAO Group, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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 12.9 · 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? (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 |
|---|---|---|---|
| * | — | Duraphat by Colgate-Palmolive Named without a submission number | |
| * | — | Durafluor by PharmaScience Named without a submission number |
What descends from it? (9)
4 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, K082198 (Dentsply Intl., Inc., 2008) has gone furthest, with 4 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 | — |
What is it indicated for?
For use as a varnish on sensitive tgeth over expoied dentin and under temporary restorétlves ané cements where post-operative sensitivity is of conCern.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982915 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982915: Sci-Pharm DFV Varnish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982915
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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