# K103461: Colgate Desensitizing Dental Cream

- Pathway: 510(k) (Traditional)
- Applicant: Colgate-Palmolive Co.
- Decided: Sep 13, 2011 after 293 days
- Product code: LBH (Varnish, Cavity)
- Device class: 2
- Regulation: 21 CFR 872.3260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931812 (1993). 16 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003482: Proclude-Sensitive, Ortek Therapeutics, Inc. (2001) Summary page 1.
- K002989: Proclude, Ortek Therapeutics, Inc. (2000) Summary page 2.
- K040473: Oravive Tooth Revitalizing Paste, Novamin Technology, Inc. (2004) Summary page 2.
- K050486: Protect Tooth Desensitizer, Sunstar Butler (2005) Summary page 2.

## Most influential descendants
- K140481: Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief Mouthwash (2014), 1 descendant of its own
- K143155: LISTERINE Sensitivity Defense Mouthrinse (2015), 0 descendants of its own

## Indications for use
For the management of sensitive teeth. Provides rapid relief from painful sensitivity of teeth to cold, heat, acids, sweets, or contact. Rapid Desensitizer

Source page: https://510kreport.com/device/K103461
Methodology: https://510kreport.com/methodology