510(k) · Cleared
ClearedSuper Seal Tooth Desensitizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phoenix Dental, Inc. · LBH Varnish, Cavity
Cleared on Mar 7, 2012 as substantially equivalent to K050486 (Sunstar Butler, 2005) and 1 other predicate after a 54-day review. Its family tree reaches back 2 generations to 2003. 6 later devices descend from it.
- Decided
- Mar 7, 2012
- Review
- 54 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K030922 (2003). 3 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK030922 VivasensIvoclar Vivadent, Inc. · 2003
- 1 generation backK050486 Protect Tooth DesensitizerSunstar Butler · 2005
- This deviceK120109 Super Seal Tooth DesensitizerPhoenix Dental, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK120176 Senzzzzz AwayCentrix, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK241489 ReminGelInter-Med, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK122708 Remesense for Sensitive TeethSylphar N.V. · 2013
- Descendant · 2 generations on · 0 of its ownK262243 Profisil FreeKettenbach GmbH & Co. KG · 2026
- Descendant · 3 generations on · 0 of its ownK132426 Sylphar Remesense Sensitivity Relief StripsSylphar N.V. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K120176Senzzzzz AwayCentrix, Inc. · 2012 · cites it directly2descendants
- K241489ReminGelInter-Med, Inc. · 2025 · cites it directly1descendant
- K122708Remesense for Sensitive TeethSylphar N.V. · 2013 · 2 generations on1descendant
- K262243Profisil FreeKettenbach GmbH & Co. KG · 2026 · 2 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| −2 | K030922 | Vivasens | Ivoclar Vivadent, Inc. | 2003 | — |
| −1 | K050486 | Protect Tooth Desensitizer | Sunstar Butler | 2005 | — |
| 0 (this device) | K120109 | Super Seal Tooth Desensitizer | Phoenix Dental, Inc. | 2012 | — |
| +1 | K120176 | Senzzzzz Away | Centrix, Inc. | 2012 | — |
| +1 | K241489 | ReminGel | Inter-Med, Inc. | 2025 | — |
| +2 | K122708 | Remesense for Sensitive Teeth | Sylphar N.V. | 2013 | — |
| +2 | K262243 | Profisil Free | Kettenbach GmbH & Co. KG | 2026 | — |
| +3 | K132426 | Sylphar Remesense Sensitivity Relief Strips | Sylphar N.V. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 12.9 · 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 |
|---|---|---|---|
| * | K050486 | Protect Tooth DesensitizerSummary page 1…Varnish, Cavity Substantially Equivalent: Protect Tooth Desensitizer LBH, Varnish, Cavity K050486 Orajel Advanced Tooth Desensitizer KLE, Agent, Tooth Bondi… | 2005 |
| * | K041680 | Orajel Advanced Tooth DesensitizerSummary page 1…Orajel Advanced Tooth Desensitizer KLE, Agent, Tooth Bonding, Resin K(041680 Device Description: Super Seal ®Tooth Desensitizer is applied with an applicator by the user to aid in dentinal sensitivity. it… | 2004 |
What descends from it? (6)
3 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 9 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K120176 (Centrix, Inc., 2012) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K050486.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
To aid in the relief from dentinal sensitivity
This could be caused by:
Cold
Heat
Acids
Sweets
Result from dental whitening agents
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120109 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120109: Super Seal Tooth Desensitizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120109
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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