# K073061: The Proxivent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Coll Partners, Ltd.
- Decided: Feb 29, 2008 after 122 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: 1 generation back to K931096 (1993). 1 ancestor in all.
4 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)
- K931096: Duraflor, Pharmascience, Inc. (1993) Summary page 1.

## Most influential descendants
- K082594: Remesense (2009), 3 descendants of its own
- K120176: Senzzzzz Away (2012), 2 descendants of its own
- K122708: Remesense for Sensitive Teeth (2013), 1 descendant of its own
- K132426: Sylphar Remesense Sensitivity Relief Strips (2014), 0 descendants of its own

## Indications for use
The Proxivent Kit is a fluoride containing varnish system intended for use as a desensitizing agent on the surface areas of hypersensitive or potentially sensitive teeth where dentin or cementum is directly or indirectly exposed.

Source page: https://510kreport.com/device/K073061
Methodology: https://510kreport.com/methodology