# K030206: APEX 90

- Pathway: 510(k) (Traditional)
- Applicant: We Dong Myung Dental Industrial Co., Ltd.
- Decided: Jan 29, 2003 after 8 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 K003603 (2001). 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)
- K003603: Bio Herador SG, Bio Header GG, Herador S, Bio Herador N, Herabond, Heraloy G, Albabond, Bio Maingold SG, Maingold SG, HE, Jelenko Co. (2001)

## Indications for use
Reconstruction of porcelain-to-metal dental restorations/reconstruction of dental restorations.

Source page: https://510kreport.com/device/K030206
Methodology: https://510kreport.com/methodology