510(k) · Cleared
ClearedSultan Tooth Root Desensitizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International, Inc. · LBH Varnish, Cavity
Cleared on Oct 3, 2007 as substantially equivalent to K071267 (Novamin Technology, Inc., 2007) and 1 other predicate after a 43-day review. Its family tree reaches back 2 generations to 2001. 5 later devices descend from it.
- Decided
- Oct 3, 2007
- Review
- 43 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010957 (2001). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK010957 Quell DesensitizerJeneric/Pentron, Inc. · 2001
- 1 generation backK033295 Butler Nucare Root Conditioner with NovaminNovamin Technology, Inc. · 2003
- This deviceK072342 Sultan Tooth Root DesensitizerDentsply International, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK082198 Durashield PlusDentsply Intl., Inc. · 2008
- Descendant · 2 generations on · 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 · 2 generations on · 1 of its ownK103160 Nupro Model 13016901CAO Group, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK140349 Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc. · 2014
Most influential descendants
Showing 5 of 5 · 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 · 2 generations on3descendants
- K100540Ascent F-Coat Model: 006-00097CAO Group, Inc. · 2010 · 2 generations on2descendants
- K103160Nupro Model 13016901CAO Group, Inc. · 2011 · 2 generations on1descendant
- K140349Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010957 | Quell Desensitizer | Jeneric/Pentron, Inc. | 2001 | — |
| −1 | K033295 | Butler Nucare Root Conditioner with Novamin | Novamin Technology, Inc. | 2003 | — |
| 0 (this device) | K072342 | Sultan Tooth Root Desensitizer | Dentsply International, Inc. | 2007 | — |
| +1 | K082198 | Durashield Plus | Dentsply Intl., Inc. | 2008 | — |
| +2 | 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 | — |
| +2 | K103160 | Nupro Model 13016901 | CAO Group, Inc. | 2011 | — |
| +3 | K140349 | Starbright 5% Sodium Fluoride Varnish | Nanova Biomaterials, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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 12.8 · 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? (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 |
|---|---|---|---|
| * | K071267 | Periosrp Tooth Root Conditioner with NovaminSummary page 1…OT DESENSITIZER CLASSIFICATION NAME: Cavity varnish 872.3260 PREDICATE DEVICES: PerioSRPTM Tooth Root Conditioner with NovaMin®9 K071267 Butler NuCare® Root Conditioner with NovaMin® K033295 DEVICE DESCRIPTION: SULTAN TOOTH ROOT DESEN… | 2007 |
| * | K033295 | Butler Nucare Root Conditioner with NovaminSummary page 1…872.3260 PREDICATE DEVICES: PerioSRPTM Tooth Root Conditioner with NovaMin®9 K071267 Butler NuCare® Root Conditioner with NovaMin® K033295 DEVICE DESCRIPTION: SULTAN TOOTH ROOT DESENSITIZER is identical to the predicate devices. This product is manufactured… | 2003 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082198 | Durashield Plus | 2008 | 4 |
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 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 3 ancestors has a recall.
- 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. 2007, 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?
SULTAN TOOTH ROOT DESENSITIZER is intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072342: Sultan Tooth Root Desensitizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072342
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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