# K040473: Oravive Tooth Revitalizing Paste

- Pathway: 510(k) (Traditional)
- Applicant: Novamin Technology, Inc.
- Decided: Mar 10, 2004 after 15 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.
3 later devices descend from it; 1 cites it directly.
0 of 6 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 1.

## Most influential descendants
- K103461: Colgate Desensitizing Dental Cream (2011), 2 descendants of its own
- 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
OraviveTM is a fluoride-free toothpaste product intended for cleaning the tooth surface on a daily basis, Clinical studies have shown that OraviveTM also provides relief from tooth sensitivity due to cold, heat, acids, sweets, or contact by the occlusion of dentin tubules.

Source page: https://510kreport.com/device/K040473
Methodology: https://510kreport.com/methodology