# K012840: Euro 45, Order-NO.: 2064

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Edelmetalle GmbH & Co.
- Decided: Oct 23, 2001 after 61 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 K944887 (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)
- K944887: Eureka Plus, J.F. Jelenko & Co., Inc. (1994) Summary page 1.

## Indications for use
EURO 45 is a gold-palladium ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing « Crowns e Short span bridges « Long span bridges and can be used for « Telescopic and milling work EURO 45 can be veneered with suitable dental ceramics as well as with dental-composites.

Source page: https://510kreport.com/device/K012840
Methodology: https://510kreport.com/methodology