510(k) · Cleared
ClearedRemesense
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remedent NV · LBH Varnish, Cavity
Cleared on Mar 19, 2009 as substantially equivalent to K061438 (Ultradent Products, Inc., 2007) and 3 other predicates after a 192-day review. Its family tree reaches back 2 generations to 1993. 3 later devices descend from it.
- Decided
- Mar 19, 2009
- Review
- 192 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K931096 (1993). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK931096 DuraflorPharmascience, Inc. · 1993
- 1 generation backK073061 The Proxivent KitColl Partners, Ltd. · 2008
- This deviceK082594 RemesenseRemedent NV · 2009
- Descendant · cites it directly · 2 of its ownK120176 Senzzzzz AwayCentrix, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK122708 Remesense for Sensitive TeethSylphar N.V. · 2013
- Descendant · 2 generations on · 0 of its ownK132426 Sylphar Remesense Sensitivity Relief StripsSylphar N.V. · 2014
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931096 | Duraflor | Pharmascience, Inc. | 1993 | — |
| −1 | K073061 | The Proxivent Kit | Coll Partners, Ltd. | 2008 | — |
| 0 (this device) | K082594 | Remesense | Remedent NV | 2009 | — |
| +1 | K120176 | Senzzzzz Away | Centrix, Inc. | 2012 | — |
| +1 | K122708 | Remesense for Sensitive Teeth | Sylphar N.V. | 2013 | — |
| +2 | K132426 | Sylphar Remesense Sensitivity Relief Strips | Sylphar N.V. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K061438 | Ultraez Desensitizing GelSummary page 1…ense Common Name Tooth Desensitizer Classification Name, Cavity Varnish Number & 872.5260 Product Code: LBH Predicate Devices: K061438 - UltraEZ, K041680 - Orajel, K983477 - SuperSeal, K073061 - Provident (details in table below) Device Des… | 2007 |
| * | K041680 | Orajel Advanced Tooth DesensitizerSummary page 1…Tooth Desensitizer Classification Name, Cavity Varnish Number & 872.5260 Product Code: LBH Predicate Devices: K061438 - UltraEZ, K041680 - Orajel, K983477 - SuperSeal, K073061 - Provident (details in table below) Device Description Device… | 2004 |
| * | K983477 | Super SealSummary page 1…sensitizer Classification Name, Cavity Varnish Number & 872.5260 Product Code: LBH Predicate Devices: K061438 - UltraEZ, K041680 - Orajel, K983477 - SuperSeal, K073061 - Provident (details in table below) Device Description Device Description: Reme… | 1998 |
| * | K073061 | The Proxivent KitSummary page 1…ation Name, Cavity Varnish Number & 872.5260 Product Code: LBH Predicate Devices: K061438 - UltraEZ, K041680 - Orajel, K983477 - SuperSeal, K073061 - Provident (details in table below) Device Description Device Description: Remesense consists of a t… | 2008 |
What descends from it? (3)
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 14.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K120176 (Centrix, Inc., 2012) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K061438.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Remesense is indicated for use as a tooth desensitizer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082594: Remesense.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082594
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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