# K023392: Agc Special Alloy

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Dental + Technik GmbH & Co. KG
- Decided: Dec 6, 2002 after 58 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 Special Alloy is a gold-platinum 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 Special Alloy can be veneered with suitable dental ceramics as well as with dental-composites. In addition, AGC Special Alloy, in the shape of wires, can be used for laser welding in operations in which dental alloy parts made of AGC Special alloy are joined to form dental restorations.

Source page: https://510kreport.com/device/K023392
Methodology: https://510kreport.com/methodology