510(k) · Cleared
ClearedSylphar Remesense Sensitivity Relief Strips
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 Feb 14, 2014 as substantially equivalent to K122708 (Sylphar N.V., 2013) after a 193-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Feb 14, 2014
- Review
- 193 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K002989 (2000). 16 ancestors in all, the oldest K931096 (1993). No later device cites it as a predicate yet.
- Root · 5 generations backK002989 ProcludeOrtek Therapeutics, Inc. · 2000
- 4 generations backK024343 Butler Gum Prophy Paste with NovaminUsbiomaterials Corp. · 2003
- 3 generations backK040858 Oralief Therapy for Sensitive TeethNovamin Technology, Inc. · 2004
- 2 generations backK120176 Senzzzzz AwayCentrix, Inc. · 2012
- 1 generation backK122708 Remesense for Sensitive TeethSylphar N.V. · 2013
- This deviceK132426 Sylphar Remesense Sensitivity Relief StripsSylphar N.V. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002989 | Proclude | Ortek Therapeutics, Inc. | 2000 | — |
| −4 | K024343 | Butler Gum Prophy Paste with Novamin | Usbiomaterials Corp. | 2003 | — |
| −3 | K040858 | Oralief Therapy for Sensitive Teeth | Novamin Technology, Inc. | 2004 | — |
| −2 | K120176 | Senzzzzz Away | Centrix, Inc. | 2012 | — |
| −1 | K122708 | Remesense for Sensitive Teeth | Sylphar N.V. | 2013 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K122708 | Remesense for Sensitive TeethSummary page 3…Predicate Device:...................... Sylphar Remesense for Sensitive Teeth 510(k) Sponsor: ....................... Sylphar N.V. 510(k) Number:........................1122708 Clearance Date: .................... 14 January 2013 FDA Product Code:................... LBH Classification Name: ..............… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 16 ancestors has a recall.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Syiphar Sensitivity Relief Strips are intended to aid in the relief of dentinal sensitivity resulting from cold, heat, acids, or sweets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132426: Sylphar Remesense Sensitivity Relief Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132426
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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