510(k) · Cleared
ClearedReminGel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inter-Med, Inc. · LBH Varnish, Cavity
Cleared on Jan 8, 2025 as substantially equivalent to K120109 (Phoenix Dental, Inc., 2012) after a 229-day review. Its family tree reaches back 3 generations to 2003. 1 later device descends from it.
- Decided
- Jan 8, 2025
- Review
- 229 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K030922 (2003). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK030922 VivasensIvoclar Vivadent, Inc. · 2003
- 2 generations backK050486 Protect Tooth DesensitizerSunstar Butler · 2005
- 1 generation backK120109 Super Seal Tooth DesensitizerPhoenix Dental, Inc. · 2012
- This deviceK241489 ReminGelInter-Med, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK262243 Profisil FreeKettenbach GmbH & Co. KG · 2026
Most influential descendants
Showing 1 of 1 · See all- K262243Profisil FreeKettenbach GmbH & Co. KG · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K030922 | Vivasens | Ivoclar Vivadent, Inc. | 2003 | — |
| −2 | K050486 | Protect Tooth Desensitizer | Sunstar Butler | 2005 | — |
| −1 | K120109 | Super Seal Tooth Desensitizer | Phoenix Dental, Inc. | 2012 | — |
| 0 (this device) | K241489 | ReminGel | Inter-Med, Inc. | 2025 | — |
| +1 | K262243 | Profisil Free | Kettenbach GmbH & Co. KG | 2026 | — |
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 |
|---|---|---|
| 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 12.8 · 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 |
|---|---|---|---|
| * | K120109 | Super Seal Tooth DesensitizerSummary page 5…nish, Cavity Classification Name: Cavity Varnish Product Code: LBH Device Class: Class 2 3. Predicate Device Primary Predicate Device Super Seal (K120109) by Phoenix Dental Inc. o Common Name: Varnish, Cavity o Classification Name: Cavity Varnish o Product Co… | 2012 |
| † | K120176 | Senzzzzz Away | 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 |
|---|---|---|---|
| K262243 | Profisil Free | 2026 | 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 22 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K262243 (Kettenbach GmbH & Co. KG, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K120109.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 relieve dental hypersensitivity caused by bleaching procedures, cold, heat, acids, or sweets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241489 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241489: ReminGel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241489
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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