# K982779: Medental Glass Ionomer Cement Type I and Mirage Glass Ionomer Cement Type 1

- Pathway: 510(k) (Traditional)
- Applicant: Medental Intl.
- Decided: Sep 30, 1998 after 54 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
Glass Ionomer cement is used in a luting application and referred to as a cement for the attachment of indirect restorations and appliances to the teeth. The glass ionomer cements also bond adhesively to tooth structure and they inhibit infiltration of oral fluids at the cement-tooth interface.

Source page: https://510kreport.com/device/K982779
Methodology: https://510kreport.com/methodology