510(k) · Cleared
ClearedOralief Otc Toothpaste 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 Mar 27, 2008 as substantially equivalent to K040858 (Novamin Technology, Inc., 2004) after a 57-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Mar 27, 2008
- Review
- 57 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002989 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK002989 ProcludeOrtek Therapeutics, Inc. · 2000
- 2 generations backK024343 Butler Gum Prophy Paste with NovaminUsbiomaterials Corp. · 2003
- 1 generation backK040858 Oralief Therapy for Sensitive TeethNovamin Technology, Inc. · 2004
- This deviceK080228 Oralief Otc Toothpaste for Sensitive TeethNovamin Technology, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK143155 LISTERINE Sensitivity Defense MouthrinseJohnson & Johnson Healthcare Products, Division of Mcneil-Pp · 2015
Most influential descendants
Showing 1 of 1 · See all- K143155LISTERINE Sensitivity Defense MouthrinseJohnson & Johnson Healthcare Products, Division of Mcneil-Pp · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002989 | Proclude | Ortek Therapeutics, Inc. | 2000 | — |
| −2 | K024343 | Butler Gum Prophy Paste with Novamin | Usbiomaterials Corp. | 2003 | — |
| −1 | K040858 | Oralief Therapy for Sensitive Teeth | Novamin Technology, Inc. | 2004 | — |
| 0 (this device) | K080228 | Oralief Otc Toothpaste for Sensitive Teeth | Novamin Technology, Inc. | 2008 | — |
| +1 | K143155 | LISTERINE Sensitivity Defense Mouthrinse | Johnson & Johnson Healthcare Products, Division of Mcneil-Pp | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K040858 | Oralief Therapy for Sensitive TeethSummary page 1…60 Product Code LBH) 3. LEGALLY MARKETED PREDICATE DEVICE: Device Name: OraliefUM Therapy for Sensitive Teeth 510(k) Number: K040858 Applicant: NovaMin Technology, Inc. 4. DEVICE DESCRIPTION: Oralief"M OTC Toothpaste for Sensitive… | 2004 |
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 |
|---|---|---|---|
| K143155 | LISTERINE Sensitivity Defense Mouthrinse | 2015 | 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 8 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K143155 (Johnson & Johnson Healthcare Products, Division of Mcneil-Pp, 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K040858.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
OraliefrM OTC Toothpaste for Sensitive Teeth is a fluoride-free daily use cleaning toothpaste that provides rapid and continual relief from tooth sensitivity 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/K080228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080228: Oralief Otc Toothpaste 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/K080228
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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