510(k) · Cleared
ClearedOralief Therapy for Sensitive Teeth
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novamin Technology, Inc. · LBH Varnish, Cavity
Cleared on Sep 2, 2004 as substantially equivalent to K024343 (Usbiomaterials Corp., 2003) after a 153-day review. Its family tree reaches back 2 generations to 2000. 7 later devices descend from it.
- Decided
- Sep 2, 2004
- Review
- 153 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002989 (2000). 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK002989 ProcludeOrtek Therapeutics, Inc. · 2000
- 1 generation backK024343 Butler Gum Prophy Paste with NovaminUsbiomaterials Corp. · 2003
- This deviceK040858 Oralief Therapy for Sensitive TeethNovamin Technology, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK120176 Senzzzzz AwayCentrix, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK220419 Apapro DesensitizerSangi Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK122708 Remesense for Sensitive TeethSylphar N.V. · 2013
- Descendant · cites it directly · 1 of its ownK080228 Oralief Otc Toothpaste for Sensitive TeethNovamin Technology, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK260830 APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity…Sangi Co., Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K120176Senzzzzz AwayCentrix, Inc. · 2012 · cites it directly2descendants
- K220419Apapro DesensitizerSangi Co., Ltd. · 2022 · cites it directly1descendant
- K122708Remesense for Sensitive TeethSylphar N.V. · 2013 · 2 generations on1descendant
- K080228Oralief Otc Toothpaste for Sensitive TeethNovamin Technology, Inc. · 2008 · cites it directly1descendant
- K260830APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)Sangi Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002989 | Proclude | Ortek Therapeutics, Inc. | 2000 | — |
| −1 | K024343 | Butler Gum Prophy Paste with Novamin | Usbiomaterials Corp. | 2003 | — |
| 0 (this device) | K040858 | Oralief Therapy for Sensitive Teeth | Novamin Technology, Inc. | 2004 | — |
| +1 | K120176 | Senzzzzz Away | Centrix, Inc. | 2012 | — |
| +1 | K220419 | Apapro Desensitizer | Sangi Co., Ltd. | 2022 | — |
| +2 | K122708 | Remesense for Sensitive Teeth | Sylphar N.V. | 2013 | — |
| +1 | K080228 | Oralief Otc Toothpaste for Sensitive Teeth | Novamin Technology, Inc. | 2008 | — |
| +2 | K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | Sangi Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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 12.8 · 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 |
|---|---|---|---|
| * | K024343 | Butler Gum Prophy Paste with NovaminSummary page 6…CONCLUSIONS: Oralief rM is considered to be substantially equivalent to the legally marketed predicate device, Butler GUM® Prophylaxis Paste with NovaMin® (K024343). The provided clinical study and biocompatibility data demonstrate the safety and efficacy of Oralief Tm for the intended u… | 2003 |
What descends from it? (7)
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 4 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K120176 (Centrix, Inc., 2012) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K024343.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Provides rapid and continual relief from tooth hypersensitivity-due to cold, heat, acids,
sweets, or contact through its action of the occlusion of dentin tubules.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040858: Oralief Therapy 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/K040858
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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