# K020481: Pulpdent Post Cement

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Apr 17, 2002 after 63 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 ResilLute: 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 Post Cement is a fluoride releasing, dual cure dental resin cement that contains no Bisphenol A. It is used to permanently cement dental posts, porcelain crowns, inlays, onlays, bridges, veneers, and periodontal splints to tooth structure. Pulpdent Post Cement is also used for bonded amalgam techniques.

Source page: https://510kreport.com/device/K020481
Methodology: https://510kreport.com/methodology