510(k) · Cleared
ClearedRemesense for Sensitive Teeth
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sylphar N.V. · LBH Varnish, Cavity
Cleared on Jan 14, 2013 as substantially equivalent to K082594 (Remedent NV, 2009) and 1 other predicate after a 132-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Jan 14, 2013
- Review
- 132 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K002989 (2000). 15 ancestors in all, the oldest K931096 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK002989 ProcludeOrtek Therapeutics, Inc. · 2000
- 3 generations backK024343 Butler Gum Prophy Paste with NovaminUsbiomaterials Corp. · 2003
- 2 generations backK040858 Oralief Therapy for Sensitive TeethNovamin Technology, Inc. · 2004
- 1 generation backK120176 Senzzzzz AwayCentrix, Inc. · 2012
- This deviceK122708 Remesense for Sensitive TeethSylphar N.V. · 2013
- Descendant · cites it directly · 0 of its ownK132426 Sylphar Remesense Sensitivity Relief StripsSylphar N.V. · 2014
Most influential descendants
Showing 1 of 1 · See all- K132426Sylphar Remesense Sensitivity Relief StripsSylphar N.V. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002989 | Proclude | Ortek Therapeutics, Inc. | 2000 | — |
| −3 | K024343 | Butler Gum Prophy Paste with Novamin | Usbiomaterials Corp. | 2003 | — |
| −2 | K040858 | Oralief Therapy for Sensitive Teeth | Novamin Technology, Inc. | 2004 | — |
| −1 | K120176 | Senzzzzz Away | Centrix, Inc. | 2012 | — |
| 0 (this device) | K122708 | Remesense for Sensitive Teeth | Sylphar N.V. | 2013 | — |
| +1 | K132426 | Sylphar Remesense Sensitivity Relief Strips | Sylphar N.V. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K082594 | RemesenseSummary page 2…desensitizer. Device Description: 'Syiphar Remesense for Sensitive Teeth' is an identical device to 'Remedent Remesense', cleared for marketing in the US by FDA under K082594. 'Remedent Remesense' was cleared as a 'prescription only' (Rx) device. The purpose of this 510(k) submission is to present addit… | 2009 |
| * | K120176 | Senzzzzz AwaySummary page 3…...... 872.3260 Predicate Device 2: ................... Centrix Senzzzz Away 510(k) Sponsor: ....................... Centrix Inc 510(k) Number: ........................ K120176 Clearance Date: ....................... 25 July 2Q12 FDA Product Code:................... LBH Classification Name: ..............… | 2012 |
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 |
|---|---|---|---|
| K132426 | Sylphar Remesense Sensitivity Relief Strips | 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 13 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K132426 (Sylphar N.V., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K082594.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Remnesense for Sensitive Teeth is intended for use as a tooth desensitizer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122708: Remesense for Sensitive Teeth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122708
Report an extraction error
Are you the manufacturer?
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