# K022663: Keradec

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Dental + Technik GmbH & Co. KG
- Decided: Oct 31, 2002 after 83 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 K851872 (1985). 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)
- K851872: Blengold Special, Heraeus Dental Gold Corp. (1985) Summary page 1.

## Indications for use
KERADEC is a fuse-on gold paste, which can be used by dental technicians to manufacture dental appliances for patients. It is intended for gold coating of white metal surfaces in cervical areas, elimination of casting cavities, gold coating of occlusal surfaces and inlay imitations. In addition, it can be used within the AGC electroforming technique to manufacture AGC Bridges with the sintering procedure.

Source page: https://510kreport.com/device/K022663
Methodology: https://510kreport.com/methodology