510(k) · Cleared
ClearedColgate Desensitizing Dental Cream
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Colgate-Palmolive Co. · LBH Varnish, Cavity
Cleared on Sep 13, 2011 as substantially equivalent to K003482 (Ortek Therapeutics, Inc., 2001) and 3 other predicates after a 293-day review. Its family tree reaches back 7 generations to 1993. 2 later devices descend from it.
- Decided
- Sep 13, 2011
- Review
- 293 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K931812 (1993). 16 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 6 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 5 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 4 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 3 generations backK982394 Prime & Bond NT Dual Cure Universal Dental Adhesive SystemDentsply Intl. · 1998
- 2 generations backK992822 Seal & Protect Protective Sealant for Exposed DentineDentsply Intl. · 1999
- 1 generation backK003482 Proclude-SensitiveOrtek Therapeutics, Inc. · 2001
- This deviceK103461 Colgate Desensitizing Dental CreamColgate-Palmolive Co. · 2011
- Descendant · cites it directly · 1 of its ownK140481 Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief…Colgate-Palmolive Company · 2014
- Descendant · 2 generations on · 0 of its ownK143155 LISTERINE Sensitivity Defense MouthrinseJohnson & Johnson Healthcare Products, Division of Mcneil-Pp · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −6 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −5 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −4 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −3 | K982394 | Prime & Bond NT Dual Cure Universal Dental Adhesive System | Dentsply Intl. | 1998 | — |
| −2 | K992822 | Seal & Protect Protective Sealant for Exposed Dentine | Dentsply Intl. | 1999 | — |
| −1 | K003482 | Proclude-Sensitive | Ortek Therapeutics, Inc. | 2001 | — |
| 0 (this device) | K103461 | Colgate Desensitizing Dental Cream | Colgate-Palmolive Co. | 2011 | — |
| +1 | K140481 | Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief Mouthwash | Colgate-Palmolive Company | 2014 | — |
| +2 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K003482 | Proclude-SensitiveSummary page 1…)) submission is intended to modify the marketing status of our legally marketed device, Rx home-use DenClude (originally called ProClude-Sensitive) Desensitizing Cream (K003482) from Prescription use to Over-the-counter use. All of the components for Colgate® Desensitizing Dental Cream (CDDC) are similar… | 2001 |
| * | K002989 | ProcludeSummary page 2…y Colgate® Desensitizing Dental Cream Rx to OTC switch < 0 Traditional 510(k) Notification Palmolive's ProClude® (K002989) and DenClude® (K003482) and the other predicate devices. 1. Trade Name: DenClude® Desensitizing Dental Cream… | 2000 |
| * | K040473 | Oravive Tooth Revitalizing PasteSummary page 2…EJR 3. Trade Name: OraviveTM Tooth Revitalizing Paste Applicant: NovaMin Technology, Inc 5 10(k) number: K040473 Product Code: LBH 4. Trade Name: ProteCtTM Tooth Desensitizer Applicant:… | 2004 |
| * | K050486 | Protect Tooth DesensitizerSummary page 2…Code: LBH 4. Trade Name: ProteCtTM Tooth Desensitizer Applicant: Sunstar Butler 5 10(k) number: K050486 Product Code: LBH Technological Characteristics The general components, intended use and application of CDDC… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140481 | Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief Mouthwash | 2014 | 1 |
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 18 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K140481 (Colgate-Palmolive Company, 2014) has gone furthest, with 1 descendant 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. 2011, 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 rapid relief from painful sensitivity of teeth to cold, heat, acids, sweets, or
contact.
Rapid Desensitizer
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103461: Colgate Desensitizing Dental Cream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103461
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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