# K993175: Gold Core 75

- 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 K943487 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943487: BIO74-PF Crown & Bridge Alloy, Jeneric/Pentron, Inc. (1994) Summary page 1.

## Indications for use
Gold Core 75 is a, high noble, yellow alloy, to be used for inlays, onlays, single crown bridges, implant superstructures and substrate for low wear products and other medium expansion lower fusing porcelains and indicret restorative composites. Particularly, OPC Low Wear, K982377, Jeneric/Pentron, which is a low temperature ceramic.

Source page: https://510kreport.com/device/K993175
Methodology: https://510kreport.com/methodology