# K143155: LISTERINE Sensitivity Defense Mouthrinse

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Healthcare Products, Division of Mcneil-Pp
- Decided: Jan 29, 2015 after 87 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: 9 generations back to K931812 (1993). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140481: Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief Mouthwash, Colgate-Palmolive Company (2014) Summary page 4.
- K080228: Oralief Otc Toothpaste for Sensitive Teeth, Novamin Technology, Inc. (2008) Summary page 4.

## Indications for use
Provides continual relief from tooth sensitivity due to cold, heat, acids, sweets, or contact. Over-the-counter use.

Source page: https://510kreport.com/device/K143155
Methodology: https://510kreport.com/methodology