# K042215: Radiopaque, Glass Ionomer Endodontic Cement

- Pathway: 510(k) (Traditional)
- Applicant: Premier Dental Products Co.
- Decided: Sep 21, 2004 after 36 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Cementation of Gutta-Percha in root canal using the single cone technique.

Source page: https://510kreport.com/device/K042215
Methodology: https://510kreport.com/methodology