# K100503: Pulpdent Copal Varnish with Fluoride

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: May 12, 2010 after 79 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
Longest line of descent: 1 generation back to K945794 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982915: Sci-Pharm DFV Varnish, Scientific Pharmaceuticals, Inc. (1999) Summary page 1.
- K945794: Duraphat, Inpharma (1995) Summary page 1.
- (no number) Copalite: named in the summary without a submission number

## Indications for use
Pulpdent Copal Varnish with Fluoride is a resin-based varnish that is applied to enamel or dentin for professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film.

Source page: https://510kreport.com/device/K100503
Methodology: https://510kreport.com/methodology