# K040567: GC Initial MC, AL and LF

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Apr 22, 2004 after 49 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K900209 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981490: Willi Geller Creation Porcelain, Jensen Industries, Inc. (1998) Summary page 1.
- K002041: Willi Geller Creation & AV Porcelain, Jensen Industries, Inc. (2000) Summary page 1.
- K002904: Willi Geller Creation and LF Porcelain, Jensen Industries, Inc. (2000) Summary page 1.

## Indications for use
This product is intended for use in fabricating oral crowns, bridges, laminate veneers, inlays and onlays for dental use.

Source page: https://510kreport.com/device/K040567
Methodology: https://510kreport.com/methodology