510(k) · Cleared
ClearedDurashield Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl., Inc. · LBH Varnish, Cavity
Cleared on Oct 29, 2008 as substantially equivalent to K982915 (Scientific Pharmaceuticals, Inc., 1999) and 1 other predicate after an 86-day review. Its family tree reaches back 3 generations to 2001. 4 later devices descend from it.
- Decided
- Oct 29, 2008
- Review
- 86 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010957 (2001). 5 ancestors in all, the oldest K982915 (1999). 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK010957 Quell DesensitizerJeneric/Pentron, Inc. · 2001
- 2 generations backK033295 Butler Nucare Root Conditioner with NovaminNovamin Technology, Inc. · 2003
- 1 generation backK072342 Sultan Tooth Root DesensitizerDentsply International, Inc. · 2007
- This deviceK082198 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 · cites it directly · 2 of its ownK100540 Ascent F-Coat Model: 006-00097CAO Group, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK103160 Nupro Model 13016901CAO Group, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK140349 Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- 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 · cites it directly2descendants
- K103160Nupro Model 13016901CAO Group, Inc. · 2011 · cites it directly1descendant
- K140349Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010957 | Quell Desensitizer | Jeneric/Pentron, Inc. | 2001 | — |
| −2 | K033295 | Butler Nucare Root Conditioner with Novamin | Novamin Technology, Inc. | 2003 | — |
| −1 | K072342 | Sultan Tooth Root Desensitizer | Dentsply International, Inc. | 2007 | — |
| 0 (this device) | K082198 | Durashield Plus | Dentsply Intl., Inc. | 2008 | — |
| +1 | K090519 | Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5%… | 3M Company | 2009 | — |
| +1 | K100540 | Ascent F-Coat Model: 006-00097 | CAO Group, Inc. | 2010 | — |
| +1 | K103160 | Nupro Model 13016901 | CAO Group, Inc. | 2011 | — |
| +2 | K140349 | Starbright 5% Sodium Fluoride Varnish | Nanova Biomaterials, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K982915 | Sci-Pharm DFV VarnishSummary page 1…Company Device 510(k) Number Date Cleared Scientific Pharmaceuticals, Sci-Pharm DFV Varnish K982915 02/12/1999 Inc. NovaMin Technology, Inc. Sultan Tooth Root K072342 10/03/2… | 1999 |
| * | K072342 | Sultan Tooth Root DesensitizerSummary page 1…tific Pharmaceuticals, Sci-Pharm DFV Varnish K982915 02/12/1999 Inc. NovaMin Technology, Inc. Sultan Tooth Root K072342 10/03/2007 Desensitizer 4. Description of Device: DUR… | 2007 |
What descends from it? (4)
3 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?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K090519 (3M Company, 2009) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K982915.
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?
DURASHIELD® PLUS is indicated for the relief of dental hypersensitivity where dentin and cementum are exposed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082198 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082198: Durashield Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082198
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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