# K993572: Ceradium V Non-Precious Ceramic Alloy

- Pathway: 510(k) (Traditional)
- Applicant: Matech, Inc.
- Decided: Dec 13, 1999 after 53 days
- Product code: EJH (Alloy, Metal, Base)
- Device class: 2
- Regulation: 21 CFR 872.3710
- 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
A- Identification: A base metal alloy is a device composed of a material such as a mixture of Nickel and Chromium B- Intended Use: This material is to be used by the dentist in the fabrication of a custom-made dental device, such as a porcelain veneer for a tooth.

Source page: https://510kreport.com/device/K993572
Methodology: https://510kreport.com/methodology