# K013411: Pulpdent Cavity Preparation IV

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corp.
- Decided: Dec 12, 2001 after 58 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 Cavity Preparation I: named in the summary without a submission number
- (no number) Ultradent Consepsis: named in the summary without a submission number
- (no number) BISCO Cavity Cleanser: named in the summary without a submission number

## Indications for use
Pulpdent Cavity Preparation IV 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 IV, an aqueous solution of chlorhexidine gluconate, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. These products 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.

Source page: https://510kreport.com/device/K013411
Methodology: https://510kreport.com/methodology