# K010957: Quell Desensitizer

- Pathway: 510(k) (Traditional)
- Applicant: Jeneric/Pentron, Inc.
- Decided: Jun 25, 2001 after 87 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
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033295: Butler Nucare Root Conditioner with Novamin (2003), 6 descendants of its own
- 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

Source page: https://510kreport.com/device/K010957
Methodology: https://510kreport.com/methodology