# K974398: Pulpdent Cavity Varnish

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corp.
- Decided: Feb 18, 1998 after 89 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Pulpdent Polyamide Dentin Liner: named in the summary without a submission number
- (no number) Pulpdent Copal Varnish: named in the summary without a submission number
- (no number) Cetylite Zarosen: named in the summary without a submission number
- (no number) Cooley & Cooley Copalite Varnish: named in the summary without a submission number

## Indications for use
Pulpdent VARNISH |, Hi, Hll, and IV are desensitizing cavity varnishes and dentinal tubule sealers. They are indicated for exposed sensitive dentin or cementumn after scaling, prophylaxis, cavity preparation and prior to any cementation and pin or post seating. Pulpdent VARNISH forms a hard protective coating which protects dentin and pulp, reduces acid diffusion from cements, minimizes marginal leaks and acts as a thermal insulator. This coating controls dentinal fluild flow by sealing the dentinal tubules and producing a physiologic barrier. Pulpdent VARNISH is used by the dental professional to contro! thermal shock and sensitivity in teeth undergoing treatment or restoration. It can be applied to all prepared cavities, to dentin and enamel, with or without the smear layer removed. Pulpdent VARNISH can be used under veneers, inlays, crowns, onlays, amalgams and composite resins and to treat cervical or root sensitivity. Pulpdent VARNISH [, ll, Il and iV are mixtures of either copal resin or polyamide resin and strontium chloride in organic solvent. The formulas for Varnish i and IV also contain the surfactant, cetyl pyridinium chioride.

Source page: https://510kreport.com/device/K974398
Methodology: https://510kreport.com/methodology