# K945794: Duraphat

- Pathway: 510(k) (Traditional)
- Applicant: Inpharma
- Decided: Jul 26, 1995 after 243 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.
11 later devices descend from it; 8 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K031932: Fluoride Varnish (2003), 2 descendants of its own
- K030488: Fluorilaq (2003), 2 descendants of its own
- K131376: Smartcoat 2.5% Naf Varnish (2013), 1 descendant of its own
- K112946: Activ Varnish (2011), 1 descendant of its own
- K250714: FluoroDose Varnish (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K945794
Methodology: https://510kreport.com/methodology