# K980660: Biogold Plus Dental Alloy

- Pathway: 510(k) (Traditional)
- Applicant: European Dental Imports, Inc.
- Decided: Apr 27, 1998 after 66 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses: precious metal bridges, bars, and posts; precious metal copings, pontics and bridges for porcelain-fused-to-metal restorations. For porcelain-fused-to-metal restorations it is intended by the manufacturer that only normal-fusing-temperature porcelain products be used with the Biogold Plus alloy. After fabrication and finishing the completed prosthesis is approved and placed in the patient’s mouth by the dentist.

Source page: https://510kreport.com/device/K980660
Methodology: https://510kreport.com/methodology