# K093620: Pulpdent Fluoride Varnish

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Mar 10, 2010 after 107 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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) Scientific Pharmaceuticals Sci-Pharm Desensitizing Varnish: named in the summary without a submission number
- (no number) Scientific Pharmaceuticals Sci-Pharm DFV Varnish: named in the summary without a submission number
- (no number) Ultradent Flor-Opal Varnish White: named in the summary without a submission number
- (no number) 3M Vanish 5% NaF White Varnish: named in the summary without a submission number
- (no number) Colgate Duraphat: named in the summary without a submission number

## Most influential descendants
- K112946: Activ Varnish (2011), 1 descendant of its own
- K151302: Clinpro Varnish (2015), 0 descendants of its own

## Indications for use
Pulpdent Fluoride Varnish is a resin-based 5% sodium fluoride varnish, formulated without volatile solvents, that is applied to enamel or dentin and is used for professional treatment of dental hypersensitivity by occluding dentinal tubules and by promoting an environment conducive to remineralization.

Source page: https://510kreport.com/device/K093620
Methodology: https://510kreport.com/methodology