# K981813: Permacem Automix Luting Cement System

- Pathway: 510(k) (Traditional)
- Applicant: Foremost Dental Mfg., Inc.
- Decided: Jul 10, 1998 after 49 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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
PermaCem® is a compomer based permanent luting cement to be applied by the dental professional prior to the cementation of crowns, bridges, inlays, onlays and veneers in patients.

Source page: https://510kreport.com/device/K981813
Methodology: https://510kreport.com/methodology