# K970205: Vitallium 2000 Alloy; Vitallium 2000 Plus Alloy; Cobalt Chrome Casting Alloy

- Pathway: 510(k) (Traditional)
- Applicant: Austenal, Inc.
- Decided: Apr 21, 1997 after 90 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
Longest line of descent: 1 generation back to K880875 (1988). 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)
- K880875: Vitallium Equipoise Alloy, Austenal Dental, Inc. (1988) Summary page 1.

## Indications for use
The above name products are intended for use as base metal casting alloys for casting removable partial denture frameworks.

Source page: https://510kreport.com/device/K970205
Methodology: https://510kreport.com/methodology