# K011661: Concord 88

- Pathway: 510(k) (Abbreviated)
- Applicant: Gateway Alloys, Inc.
- Decided: Aug 27, 2001 after 90 days
- Product code: EJT (Alloy, Gold-Based Noble Metal)
- Device class: 2
- Regulation: 21 CFR 872.3060
- 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
CONCORD 88 (PM-43) is a yellow colored gold/platinum dental casting alloy for restorations subject to high stress and that require porcelain enamels be fused to some of the surfaces. It may also be used as a Type III (hard) crown and bridge alloy. It is intended for use in the manufacture of single units, % crowns, and short-span bridgework.

Source page: https://510kreport.com/device/K011661
Methodology: https://510kreport.com/methodology