# K034049: Herador EC, PF, C, H, NH, G, GG and MP; Heraloy U and G; Herabond N; Albabond C, B and a; Bio Heranorm

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer,GmbH
- Decided: Mar 1, 2004 after 62 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
Reconstruction of porcelain to metal dental restorations/reconstruction of dental restorations.

Source page: https://510kreport.com/device/K034049
Methodology: https://510kreport.com/methodology