# K250222: SDF Pro

- Pathway: 510(k) (Traditional)
- Applicant: Belport Company, Inc., Gingi-Pak
- Decided: May 7, 2025 after 100 days
- Product code: PHR (Diammine Silver Fluoride Dental Hypersensitivity Varnish)
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
SDF Pro is intended to be used by dental professionals to treat tooth hypersensitivity. For use in adults over the age of 21.

Source page: https://510kreport.com/device/K250222
Methodology: https://510kreport.com/methodology