# K192381: DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor

- Pathway: 510(k) (Traditional)
- Applicant: Scientific Pharmaceuticals
- Decided: Feb 18, 2020 after 172 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 K040098 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153334: Oral-B 5% Sodium Fluoride Varnish, Young Dental Manufacturing Co. 1, LLC (2016) Summary page 6.

## Indications for use
SciPharm's DFV Desensitizing Varnish is a fluoride-containing resin preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.

Source page: https://510kreport.com/device/K192381
Methodology: https://510kreport.com/methodology