# K990670: Helioform Gold-Based Alloy

- Pathway: 510(k) (Traditional)
- Applicant: C. Hafner GmbH & Co.
- Decided: Apr 2, 1999 after 31 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 K980613 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980613: Progold Electrocoping System, Micro Dental Laboratories (1998) Summary page 1.

## Most influential descendants
- K032267: R&D Designation AP-052-5 (2003), 0 descendants of its own

## Indications for use
Indicated for fixed and removable dental tooth replacement as follows: Crowns Inlays, Onlays, Overlays, Partial Crowns Telescopes, Cones, Overdentures Direct Technique Double Crown Systems Implant Suprastructures Bridge Structures Baseplates

Source page: https://510kreport.com/device/K990670
Methodology: https://510kreport.com/methodology