# K033295: Butler Nucare Root Conditioner with Novamin

- Pathway: 510(k) (Traditional)
- Applicant: Novamin Technology, Inc.
- Decided: Oct 28, 2003 after 14 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 K010957 (2001). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010957: Quell Desensitizer, Jeneric/Pentron, Inc. (2001)

## Most influential descendants
- K072342: Sultan Tooth Root Desensitizer (2007), 5 descendants of its own
- K082198: Durashield Plus (2008), 4 descendants of its own
- K090519: Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5% Fluoride Varnish, Model 12247 (2009), 3 descendants of its own
- K100540: Ascent F-Coat Model: 006-00097 (2010), 2 descendants of its own
- K103160: Nupro Model 13016901 (2011), 1 descendant of its own

## Indications for use
Butler Nucare@Root Conditioner with NovaMin@is a two-phase product intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin. Studies have shown that Butler Nucare@Root Conditioner with NovaMin@is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.

Source page: https://510kreport.com/device/K033295
Methodology: https://510kreport.com/methodology