# K002581: Duragard Sodium Fluoride Varnish

- Pathway: 510(k) (Traditional)
- Applicant: Sultan Dental Products, Ltd.
- Decided: Oct 20, 2000 after 63 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K031932: Fluoride Varnish (2003), 2 descendants of its own
- K122331: Cavity Varnish (2012), 0 descendants of its own
- K080814: Voco Profluorid Varnish (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K002581
Methodology: https://510kreport.com/methodology