# K022252: Sterngold 1, Model 1127781

- Pathway: 510(k) (Abbreviated)
- Applicant: Sterngold
- Decided: Sep 19, 2002 after 69 days
- Product code: EJS (Alloy, Other 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 K895064 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905330: Harmony Line Alloys, Ivoclar North America, Inc. (1990) Summary page 1.
- K895064: Monogram II, Leach and Dillon Co., Inc. (1989) Summary page 1.

## Indications for use
Precious Alloy for use in Crown and Bridge Dental Restorations.

Source page: https://510kreport.com/device/K022252
Methodology: https://510kreport.com/methodology