# K040858: Oralief Therapy for Sensitive Teeth

- Pathway: 510(k) (Traditional)
- Applicant: Novamin Technology, Inc.
- Decided: Sep 2, 2004 after 153 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: 2 generations back to K002989 (2000). 2 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024343: Butler Gum Prophy Paste with Novamin, Usbiomaterials Corp. (2003) Summary page 6.

## Most influential descendants
- K120176: Senzzzzz Away (2012), 2 descendants of its own
- K220419: Apapro Desensitizer (2022), 1 descendant of its own
- K122708: Remesense for Sensitive Teeth (2013), 1 descendant of its own
- K080228: Oralief Otc Toothpaste for Sensitive Teeth (2008), 1 descendant of its own
- K260830: APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) (2026), 0 descendants of its own

## Indications for use
Provides rapid and continual relief from tooth hypersensitivity-due to cold, heat, acids, sweets, or contact through its action of the occlusion of dentin tubules.

Source page: https://510kreport.com/device/K040858
Methodology: https://510kreport.com/methodology