# K082198: Durashield Plus

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl., Inc.
- Decided: Oct 29, 2008 after 86 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: 3 generations back to K010957 (2001). 5 ancestors in all.
4 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)
- K982915: Sci-Pharm DFV Varnish, Scientific Pharmaceuticals, Inc. (1999) Summary page 1.
- K072342: Sultan Tooth Root Desensitizer, Dentsply International, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K140349: Starbright 5% Sodium Fluoride Varnish (2014), 0 descendants of its own

## Indications for use
DURASHIELD® PLUS is indicated for the relief of dental hypersensitivity where dentin and cementum are exposed.

Source page: https://510kreport.com/device/K082198
Methodology: https://510kreport.com/methodology