# K993897: Cergogold

- Pathway: 510(k) (Traditional)
- Applicant: Degussa - Ney Dental, Inc.
- Decided: Jan 10, 2000 after 55 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K033667: Carrara Press System (2004), 0 descendants of its own

## Indications for use
This product is ceramic core material used in the manufacture of all-ceramic dental restorations. The product is sold in the form of pellets and is processed with currently marketed pressing furnaces.

Source page: https://510kreport.com/device/K993897
Methodology: https://510kreport.com/methodology