# K040236: Pulpdent VLC Resin Cement

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Apr 20, 2004 after 78 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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 Post Cement: named in the summary without a submission number
- (no number) Pulpdent ResiLute: named in the summary without a submission number
- (no number) Kuraray /J. Morita Panavia F: named in the summary without a submission number
- (no number) ESPE Compolute Aplicap: named in the summary without a submission number
- (no number) Ivoclar / Vivadent Variolink II: named in the summary without a submission number

## Indications for use
Pulpdent VLC. Resin Cement is a fluoride releasing, visible light-cure dental resin cement that contains no Bisphenol A. It is used to permanently cement ceramic restorations, such as Cerec, porcelain crowns, inlays, onlays, bridges, veneers, and periodontal splints to tooth structure.

Source page: https://510kreport.com/device/K040236
Methodology: https://510kreport.com/methodology