# K020347: Agc Speziallegierung

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Edelmetalle GmbH & Co.
- Decided: Apr 24, 2002 after 79 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: 2 generations back to K952122 (1995). 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)
- K012826: Bioporta G, Model 2052, Wieland Edelmetalle GmbH & Co. (2001) Summary page 1.

## Indications for use
AGC Speziallegierung is a gold-platinum ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing ¢ Inlays/Onlays * Crowns « Short span bridges » Long span bridges « Pontics for AGC bridges « Removable partials and can be used for « Telescopic and milling work AGC Speziallegierung can be veneered with suitable dental ceramics as well as with - dental-composites.

Source page: https://510kreport.com/device/K020347
Methodology: https://510kreport.com/methodology