510(k) · Cleared
ClearedColgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief Mouthwash
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Colgate-Palmolive Company · LBH Varnish, Cavity
Cleared on Jun 5, 2014 as substantially equivalent to K103461 (Colgate-Palmolive Co., 2011) after a 99-day review. Its family tree reaches back 8 generations to 1993. 1 later device descends from it.
- Decided
- Jun 5, 2014
- Review
- 99 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K931812 (1993). 17 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 7 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 6 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 5 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 4 generations backK982394 Prime & Bond NT Dual Cure Universal Dental Adhesive SystemDentsply Intl. · 1998
- 3 generations backK992822 Seal & Protect Protective Sealant for Exposed DentineDentsply Intl. · 1999
- 2 generations backK003482 Proclude-SensitiveOrtek Therapeutics, Inc. · 2001
- 1 generation backK103461 Colgate Desensitizing Dental CreamColgate-Palmolive Co. · 2011
- This deviceK140481 Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief…Colgate-Palmolive Company · 2014
- 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 |
|---|---|---|---|---|---|
| −8 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −7 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −6 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −5 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −4 | K982394 | Prime & Bond NT Dual Cure Universal Dental Adhesive System | Dentsply Intl. | 1998 | — |
| −3 | K992822 | Seal & Protect Protective Sealant for Exposed Dentine | Dentsply Intl. | 1999 | — |
| −2 | K003482 | Proclude-Sensitive | Ortek Therapeutics, Inc. | 2001 | — |
| −1 | K103461 | Colgate Desensitizing Dental Cream | Colgate-Palmolive Co. | 2011 | — |
| 0 (this device) | K140481 | Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief Mouthwash | Colgate-Palmolive Company | 2014 | — |
| +1 | K143155 | LISTERINE Sensitivity Defense Mouthrinse | Johnson & Johnson Healthcare Products, Division of Mcneil-Pp | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
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 |
|---|---|---|---|
| * | K103461 | Colgate Desensitizing Dental CreamSummary page 1…tics of CDDC our cleared predicate device. The cornonients of CDMW have previously been cleared by CDRH in dental devices, including ColgateE Desensitizing Dental Cream (K103461). The technological characteristics of CDMW differ from CDDC but the fundamental scientific technology is the same. === Page 2 =… | 2011 |
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 21 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 17 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.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
For the management of sensitive teeth.
Provides relief from painful sensitivity of teeth to cold, heat, acids, sweets, or contact.
Desensitizes teeth for lasting relief
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140481: Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief Mouthwash.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140481
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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