# K012838: ERO50, Order-NO.: 2070

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Edelmetalle GmbH & Co.
- Decided: Oct 23, 2001 after 61 days
- Product code: EJT (Alloy, Gold-Based 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 K951787 (1995). 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)
- K951787: Degubond 4, Degussa Corp. (1995) Summary page 1.

## Indications for use
EURO 50 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 « Short span bridges e Long span bridges and can be used for e Telescopic and milling work EURO 50 can be veneered with suitable dental ceramics as well as with dental composites.

Source page: https://510kreport.com/device/K012838
Methodology: https://510kreport.com/methodology