510(k) · Cleared
ClearedThe Proxivent Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coll Partners, Ltd. · LBH Varnish, Cavity
Cleared on Feb 29, 2008 as substantially equivalent to K931096 (Pharmascience, Inc., 1993) after a 122-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.
- Decided
- Feb 29, 2008
- Review
- 122 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931096 (1993). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK931096 DuraflorPharmascience, Inc. · 1993
- This deviceK073061 The Proxivent KitColl Partners, Ltd. · 2008
- Descendant · cites it directly · 3 of its ownK082594 RemesenseRemedent NV · 2009
- Descendant · 2 generations on · 2 of its ownK120176 Senzzzzz AwayCentrix, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK122708 Remesense for Sensitive TeethSylphar N.V. · 2013
- Descendant · 3 generations on · 0 of its ownK132426 Sylphar Remesense Sensitivity Relief StripsSylphar N.V. · 2014
Most influential descendants
Showing 4 of 4 · See all- K082594RemesenseRemedent NV · 2009 · cites it directly3descendants
- K120176Senzzzzz AwayCentrix, Inc. · 2012 · 2 generations on2descendants
- K122708Remesense for Sensitive TeethSylphar N.V. · 2013 · 2 generations on1descendant
- K132426Sylphar Remesense Sensitivity Relief StripsSylphar N.V. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931096 | Duraflor | Pharmascience, Inc. | 1993 | — |
| 0 (this device) | K073061 | The Proxivent Kit | Coll Partners, Ltd. | 2008 | — |
| +1 | K082594 | Remesense | Remedent NV | 2009 | — |
| +2 | K120176 | Senzzzzz Away | Centrix, Inc. | 2012 | — |
| +2 | K122708 | Remesense for Sensitive Teeth | Sylphar N.V. | 2013 | — |
| +3 | K132426 | Sylphar Remesense Sensitivity Relief Strips | Sylphar N.V. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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? (1)
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 |
|---|---|---|---|
| * | K931096 | DuraflorSummary page 1…Kit Predicate Devices: Ihe Proxivent kit is substantially equivalent t:: both Duraflor® dental cavity varnish nmnrifhacuiredt by Pharmascience Inc. Canada, ::ubject of K93 1096, and Duraphat( den h~IItcavity varnish, subject of K93 1096, mantufactured initially by Inpharma and Wocim Pharma in Germany and… | 1993 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082594 | Remesense | 2009 | 3 |
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?
- Its one ancestor has no recall.
- Of its descendants, K082594 (Remedent NV, 2009) has gone furthest, with 3 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. 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?
The Proxivent Kit is a fluoride containing varnish system intended for use as a desensitizing agent on the surface areas of hypersensitive or potentially sensitive teeth where dentin or cementum is directly or indirectly exposed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073061: The Proxivent Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073061
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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