510(k) · Cleared
ClearedQuell Desensitizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeneric/Pentron, Inc. · LBH Varnish, Cavity
Cleared on Jun 25, 2001 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jun 25, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK010957 Quell DesensitizerJeneric/Pentron, Inc. · 2001
- Descendant · cites it directly · 6 of its ownK033295 Butler Nucare Root Conditioner with NovaminNovamin Technology, Inc. · 2003
- Descendant · 2 generations on · 5 of its ownK072342 Sultan Tooth Root DesensitizerDentsply International, Inc. · 2007
- Descendant · 3 generations on · 4 of its ownK082198 Durashield PlusDentsply Intl., Inc. · 2008
- Descendant · 4 generations on · 3 of its ownK090519 Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish…3M Company · 2009
- Descendant · 4 generations on · 2 of its ownK100540 Ascent F-Coat Model: 006-00097CAO Group, Inc. · 2010
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K033295Butler Nucare Root Conditioner with NovaminNovamin Technology, Inc. · 2003 · cites it directly6descendants
- K072342Sultan Tooth Root DesensitizerDentsply International, Inc. · 2007 · 2 generations on5descendants
- K082198Durashield PlusDentsply Intl., Inc. · 2008 · 3 generations on4descendants
- K090519Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5% Fluoride…3M Company · 2009 · 4 generations on3descendants
- K100540Ascent F-Coat Model: 006-00097CAO Group, Inc. · 2010 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010957 | Quell Desensitizer | Jeneric/Pentron, Inc. | 2001 | — |
| +1 | K033295 | Butler Nucare Root Conditioner with Novamin | Novamin Technology, Inc. | 2003 | — |
| +2 | K072342 | Sultan Tooth Root Desensitizer | Dentsply International, Inc. | 2007 | — |
| +3 | K082198 | Durashield Plus | Dentsply Intl., Inc. | 2008 | — |
| +4 | K090519 | Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5%… | 3M Company | 2009 | — |
| +4 | K100540 | Ascent F-Coat Model: 006-00097 | CAO Group, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 12.9 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
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?
- Of its descendants, K033295 (Novamin Technology, Inc., 2003) has gone furthest, with 6 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/K010957 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010957: Quell Desensitizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010957
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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