# K994181: Pulpdent Cavity Preparation II, Pulpdent Cavity Preparation II Wuth Fluoride

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corp.
- Decided: Feb 29, 2000 after 81 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Pulpdent Cavity Preparation II is used by the dental professional as one step in the preparation of teeth for veneers, inlays, crowns, onlays, amalgam and composite resin restorations. Pulpdent Cavity Preparation II, an aqueous solution of chlorhexidine gluconate, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. It can also be used prior to sealing dentin tubules. Recent studies have suggested that this cleansing step reduces micro leakage sensitivity in teeth undergoing treatment or restoration. Pulpdent makes no claim as to the antimicrobial effect of chlorhexidine gluconate. Pulpdent Cavity Preparation II with Fluoride combines all the features of Pulpdent Cavity Preparation II with the addition of sodium fluoride as a stabilizer. Pulpdent makes no therapeutic claim with regard to the addition of fluoride.

Source page: https://510kreport.com/device/K994181
Methodology: https://510kreport.com/methodology