# K982915: Sci-Pharm DFV Varnish

- Pathway: 510(k) (Traditional)
- Applicant: Scientific Pharmaceuticals, Inc.
- Decided: Feb 12, 1999 after 177 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.
9 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Duraphat by Colgate-Palmolive: named in the summary without a submission number
- (no number) Durafluor by PharmaScience: named in the summary without a submission number

## Most influential descendants
- K082198: Durashield Plus (2008), 4 descendants of its own
- K090519: Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5% Fluoride Varnish, Model 12247 (2009), 3 descendants of its own
- K100540: Ascent F-Coat Model: 006-00097 (2010), 2 descendants of its own
- K030488: Fluorilaq (2003), 2 descendants of its own
- K103160: Nupro Model 13016901 (2011), 1 descendant of its own

## Indications for use
For use as a varnish on sensitive tgeth over expoied dentin and under temporary restorétlves ané cements where post-operative sensitivity is of conCern.

Source page: https://510kreport.com/device/K982915
Methodology: https://510kreport.com/methodology