# K993173: Gold Core 55

- Pathway: 510(k) (Traditional)
- Applicant: Jeneric/Pentron, Inc.
- Decided: Oct 26, 1999 after 34 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
Longest line of descent: 1 generation back to K922958 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922958: KB58-KF, Jeneric/Pentron, Inc. (1993) Summary page 1.

## Most influential descendants
- K023501: Gold Core 35 (2002), 0 descendants of its own

## Indications for use
Gold Core 55 is a Type IV, high noble, yellow alloy to be used for inlays, onlays, single crown briges, implant superstructures and substrate for low wear products and other medium expansion lower fusing porcelains and indirect restorative composites. Particularly, OPC Low Wecar, K982377, Jeneric/Pencron, which 1s a low temperature ceramic.

Source page: https://510kreport.com/device/K993173
Methodology: https://510kreport.com/methodology