# K961893: Duraflor

- Pathway: 510(k) (Traditional)
- Applicant: Pharmascience, Inc.
- Decided: Aug 14, 1996 after 90 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.
6 later devices descend from it; 5 cite it directly.
0 of 7 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
- K030488: Fluorilaq (2003), 2 descendants of its own
- K140349: Starbright 5% Sodium Fluoride Varnish (2014), 0 descendants of its own
- K113146: PCXX Varnish (2012), 0 descendants of its own
- K102808: MI Varnish (2010), 0 descendants of its own
- K090597: Fluorilaq Sodium Fluoride Cavity Varnish (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K961893
Methodology: https://510kreport.com/methodology