510(k) · Cleared
ClearedNupro Model 13016901
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 Jan 6, 2011 as substantially equivalent to K100540 (CAO Group, Inc., 2010) and 1 other predicate after a 72-day review. Its family tree reaches back 6 generations to 2001. 1 later device descends from it.
- Decided
- Jan 6, 2011
- Review
- 72 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K010957 (2001). 9 ancestors in all, the oldest K802926 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK010957 Quell DesensitizerJeneric/Pentron, Inc. · 2001
- 5 generations backK033295 Butler Nucare Root Conditioner with NovaminNovamin Technology, Inc. · 2003
- 4 generations backK072342 Sultan Tooth Root DesensitizerDentsply International, Inc. · 2007
- 3 generations backK082198 Durashield PlusDentsply Intl., Inc. · 2008
- 2 generations backK090519 Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish…3M Company · 2009
- 1 generation backK100540 Ascent F-Coat Model: 006-00097CAO Group, Inc. · 2010
- This deviceK103160 Nupro Model 13016901CAO Group, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK140349 Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K140349Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010957 | Quell Desensitizer | Jeneric/Pentron, Inc. | 2001 | — |
| −5 | K033295 | Butler Nucare Root Conditioner with Novamin | Novamin Technology, Inc. | 2003 | — |
| −4 | K072342 | Sultan Tooth Root Desensitizer | Dentsply International, Inc. | 2007 | — |
| −3 | K082198 | Durashield Plus | Dentsply Intl., Inc. | 2008 | — |
| −2 | 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 | — |
| 0 (this device) | K103160 | Nupro Model 13016901 | CAO Group, Inc. | 2011 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K100540 | Ascent F-Coat Model: 006-00097Summary page 1…rnish Product Classification: Varnish, Cavity Legally Marketed Predicate Devices for Substantial Equivalence: Ascent F-Coat, manufactured by GAO Group. Inc. (K100540) C2- Durahield. manufactured by Dentsplv International, Inc. (K082 198) Rationale for Substantial Equivalence:… | 2010 |
| * | K082198 | Durashield PlusSummary page 1…icate Devices for Substantial Equivalence: Ascent F-Coat, manufactured by GAO Group. Inc. (K100540) C2- Durahield. manufactured by Dentsplv International, Inc. (K082 198) Rationale for Substantial Equivalence: The aforementioned varnishes share similar indications for use on teeth for all… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140349 | Starbright 5% Sodium Fluoride Varnish | 2014 | 0 |
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 10 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K140349 (Nanova Biomaterials, Inc., 2014) has gone furthest, with 0 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. 2011, 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?
NUPRO® cavity varnish is indicated for the coating or occlusion of exposed dentin tubules under temporary restorations, and for the treatment of hypersensitive teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103160: Nupro Model 13016901.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103160
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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