510(k) · Cleared
ClearedProtect Tooth Desensitizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunstar Butler · LBH Varnish, Cavity
Cleared on Jun 7, 2005 as substantially equivalent to K030922 (Ivoclar Vivadent, Inc., 2003) and 1 other predicate after a 102-day review. Its family tree reaches back 1 generation to 2003. 10 later devices descend from it.
- Decided
- Jun 7, 2005
- Review
- 102 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K030922 (2003). 2 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK030922 VivasensIvoclar Vivadent, Inc. · 2003
- This deviceK050486 Protect Tooth DesensitizerSunstar Butler · 2005
- Descendant · cites it directly · 6 of its ownK120109 Super Seal Tooth DesensitizerPhoenix Dental, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK120176 Senzzzzz AwayCentrix, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK103461 Colgate Desensitizing Dental CreamColgate-Palmolive Co. · 2011
- Descendant · 2 generations on · 1 of its ownK241489 ReminGelInter-Med, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK140481 Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief…Colgate-Palmolive Company · 2014
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K120109Super Seal Tooth DesensitizerPhoenix Dental, Inc. · 2012 · cites it directly6descendants
- K120176Senzzzzz AwayCentrix, Inc. · 2012 · cites it directly2descendants
- K103461Colgate Desensitizing Dental CreamColgate-Palmolive Co. · 2011 · cites it directly2descendants
- K241489ReminGelInter-Med, Inc. · 2025 · 2 generations on1descendant
- K140481Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief MouthwashColgate-Palmolive Company · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030922 | Vivasens | Ivoclar Vivadent, Inc. | 2003 | — |
| 0 (this device) | K050486 | Protect Tooth Desensitizer | Sunstar Butler | 2005 | — |
| +1 | K120109 | Super Seal Tooth Desensitizer | Phoenix Dental, Inc. | 2012 | — |
| +1 | K120176 | Senzzzzz Away | Centrix, Inc. | 2012 | — |
| +1 | K103461 | Colgate Desensitizing Dental Cream | Colgate-Palmolive Co. | 2011 | — |
| +2 | K241489 | ReminGel | Inter-Med, Inc. | 2025 | — |
| +2 | K140481 | Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief Mouthwash | Colgate-Palmolive Company | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K030922 | VivasensSummary page 2…r £.5 Classification Name Varnish, cavity 8.6 Predicate Device Protect is substantially equivalent to Vivasens (K030922), manufactured by Ivoclar Vivadent, Inc. and Orajel Advanced Tooth Desensitizer (K041680). & 7 Intend… | 2003 |
| * | K041680 | Orajel Advanced Tooth DesensitizerSummary page 2…icate Device Protect is substantially equivalent to Vivasens (K030922), manufactured by Ivoclar Vivadent, Inc. and Orajel Advanced Tooth Desensitizer (K041680). & 7 Intended Use ProtectTM Tooth Desensitizer is a film-like varnish indicated for the treatment o… | 2004 |
What descends from it? (10)
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?
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?
ProtectTM Tooth Desensitizer is a film-like varnish indicated for the treatment of tooth sensitivities.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K050486 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050486: Protect Tooth Desensitizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050486
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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