# K980990: Polycarboxylate Cement

- Pathway: 510(k) (Traditional)
- Applicant: Medental Intl.
- Decided: Jul 31, 1998 after 136 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
This is a chemically activated adhesive that is used in the cementation of inlays, crowns, bridges, facings, and orthodontic brackets. It may also be used as a cavity lining under all restorative materials or following root canal treatment. This adhesive is also used in the cementation of temporary fillings and fillings in deciduous teeth.

Source page: https://510kreport.com/device/K980990
Methodology: https://510kreport.com/methodology