# K022469: ECO E4

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Dental + Technik GmbH & Co. KG
- Decided: Sep 18, 2002 after 54 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 K911675 (1991). 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)
- K911675: Pagalin 2, Metalor Dental USA Corp. (1991) Summary page 1.

## Indications for use
Eco..E4 is a silver-palladium casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Inlays/oniays Crowns Short span bridges Long span bridges Eco E4 can be veneered with suitable dental comp&ites.

Source page: https://510kreport.com/device/K022469
Methodology: https://510kreport.com/methodology