# K250714: FluoroDose Varnish

- Pathway: 510(k) (Traditional)
- Applicant: Centrix, Inc.
- Decided: Nov 21, 2025 after 256 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 K945794 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040098: Varnishamerica, Medical Products Laboratories, Inc. (2004) Summary page 5.
- K131376: Smartcoat 2.5% Naf Varnish, Elevate Oral Care (2013) Summary page 5.

## Indications for use
Treatment of dental hypersensitivity and reduction of post-operative sensitivity.

Source page: https://510kreport.com/device/K250714
Methodology: https://510kreport.com/methodology