510(k) · Cleared
ClearedAscent F-Coat Model: 006-00097
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CAO Group, Inc. · LBH Varnish, Cavity
Cleared on Sep 23, 2010 as substantially equivalent to K090519 (3M Company, 2009) and 1 other predicate after a 210-day review. Its family tree reaches back 5 generations to 2001. 2 later devices descend from it.
- Decided
- Sep 23, 2010
- Review
- 210 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K010957 (2001). 8 ancestors in all, the oldest K802926 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK010957 Quell DesensitizerJeneric/Pentron, Inc. · 2001
- 4 generations backK033295 Butler Nucare Root Conditioner with NovaminNovamin Technology, Inc. · 2003
- 3 generations backK072342 Sultan Tooth Root DesensitizerDentsply International, Inc. · 2007
- 2 generations backK082198 Durashield PlusDentsply Intl., Inc. · 2008
- 1 generation backK090519 Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish…3M Company · 2009
- This deviceK100540 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010957 | Quell Desensitizer | Jeneric/Pentron, Inc. | 2001 | — |
| −4 | K033295 | Butler Nucare Root Conditioner with Novamin | Novamin Technology, Inc. | 2003 | — |
| −3 | K072342 | Sultan Tooth Root Desensitizer | Dentsply International, Inc. | 2007 | — |
| −2 | K082198 | Durashield Plus | Dentsply Intl., Inc. | 2008 | — |
| −1 | K090519 | Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5%… | 3M Company | 2009 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1980 | 1 | 0 |
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K090519 | Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5% Fluoride… | 2009 |
| * | K082198 | Durashield PlusSummary page 1…Marketed Predicate Devices for Substantial Equivalence: Vanish Varnish, manufactured by 3M Company (KO905 19) DuraShield. manufactured by Dentsplv International. Inc. (K082198) Rationale for Substantial Equivalence: The aforementioned varnishes share similar indications for use on teeth for all… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103160 | Nupro Model 13016901 | 2011 | 1 |
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 9 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K103160 (CAO Group, Inc., 2011) has gone furthest, with 1 descendant 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. 2010, 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?
Ascent F-Coat is indicated for the coating of exposed dentin under temporary restorations, and for the treatment of hypersensitive teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100540 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100540: Ascent F-Coat Model: 006-00097.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100540
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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