# K003603: Bio Herador SG, Bio Header GG, Herador S, Bio Herador N, Herabond, Heraloy G, Albabond, Bio Maingold SG, Maingold SG, HE

- Pathway: 510(k) (Traditional)
- Applicant: Jelenko Co.
- Decided: Jan 10, 2001 after 50 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K033446: APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82 (2003), 0 descendants of its own
- K033435: E-Sarang 86, DM78, DM55 (2003), 0 descendants of its own
- K030206: APEX 90 (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K003603
Methodology: https://510kreport.com/methodology