# K080228: Oralief Otc Toothpaste for Sensitive Teeth

- Pathway: 510(k) (Traditional)
- Applicant: Novamin Technology, Inc.
- Decided: Mar 27, 2008 after 57 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: 3 generations back to K002989 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040858: Oralief Therapy for Sensitive Teeth, Novamin Technology, Inc. (2004) Summary page 1.

## Most influential descendants
- K143155: LISTERINE Sensitivity Defense Mouthrinse (2015), 0 descendants of its own

## Indications for use
OraliefrM OTC Toothpaste for Sensitive Teeth is a fluoride-free daily use cleaning toothpaste that provides rapid and continual relief from tooth sensitivity due to cold, heat, acids, sweets or contact, through its action of the occlusion of dentin tubules

Source page: https://510kreport.com/device/K080228
Methodology: https://510kreport.com/methodology