# K062389: Z-Block, Models 20/19, 40/19, 55/19

- Pathway: 510(k) (Traditional)
- Applicant: Foundation Milling Centre
- Decided: Aug 21, 2006 after 5 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: 1 generation back to K051705 (2005). 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)
- K051705: Ips E.Max Cad/Ips E.Max Zircad, Ivoclar Vivadent, Inc. (2005) Summary page 1.

## Indications for use
This product is indicated for use as a substructure for Porcelain fused to ceramic fixed dental restorations; namely crowns and bridges. Foundation Milling Center Z-Blocks are machined using CAD/CAM technology.

Source page: https://510kreport.com/device/K062389
Methodology: https://510kreport.com/methodology