# K994182: Pulpdent Cavity Preparation 1, Pulpdent Cavity Preparation 1 with Fluoride

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corp.
- Decided: Feb 23, 2000 after 75 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 I 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 I, an aqueous solution of the disodium salt of ethylenediaminetetraacetic acid dihydrate and benzalkonium chloride, 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 step reduces micro leakage sensitivity in teeth undergoing treatment or restoration. Pulpdent makes no claim as to the antimicrobial effect of benzalkonium chloride. Pulpdent Cavity Preparation I with Fluoride has the advantage of increased stability from the addition of sodium fluoride. Pulpdent makes no therapeutic claim with regard to the addition of sodium fluoride.

Source page: https://510kreport.com/device/K994182
Methodology: https://510kreport.com/methodology