510(k) · Cleared
ClearedFluorilaq
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pascal Co., Inc. · LBH Varnish, Cavity
Cleared on May 2, 2003 as substantially equivalent to K982915 (Scientific Pharmaceuticals, Inc., 1999) and 2 other predicates after a 77-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- May 2, 2003
- Review
- 77 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K945794 (1995). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK945794 DuraphatInpharma · 1995
- This deviceK030488 FluorilaqPascal Co., Inc. · 2003
- Descendant · cites it directly · 0 of its ownK113146 PCXX VarnishRoss Healthcare, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK090597 Fluorilaq Sodium Fluoride Cavity VarnishPascal Co., Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945794 | Duraphat | Inpharma | 1995 | — |
| 0 (this device) | K030488 | Fluorilaq | Pascal Co., Inc. | 2003 | — |
| +1 | K113146 | PCXX Varnish | Ross Healthcare, Inc. | 2012 | — |
| +1 | K090597 | Fluorilaq Sodium Fluoride Cavity Varnish | Pascal Co., Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 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? (4)
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 |
|---|---|---|---|
| * | K982915 | Sci-Pharm DFV VarnishSummary page 1…nearly identical to (for example ) the following products that are currently on the market, having been cleared by 510(k)s: -5:1O(k) K982915 Number Name of Device Sci-Pharm DVF Varnish… | 1999 |
| * | K945794 | DuraphatSummary page 1…Company Scientific Pharmaceuticals, Inc. K945794 Duraphat Inpharma K961893 Duraflor… | 1995 |
| * | K961893 | DuraflorSummary page 1…Scientific Pharmaceuticals, Inc. K945794 Duraphat Inpharma K961893 Duraflor Pharmascience, Inc. The document, ”Guidance on the CDRH Premarket… | 1996 |
| * | — | Varnish, cavity Named without a submission number |
What descends from it? (2)
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?
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?
Intended for use as a varnish on sensitive teeth over exposed dentin under temporary restoratives and cements where post-operative sensitivity is a concern and to improve quality and functionality of restorations when used in conjunction with dental restoratives and cements. To seal dentinal tubules in cavity preparations or on sensitive root surfaces.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030488: Fluorilaq.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030488
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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