# K093571: ZR Dental Block

- Pathway: 510(k) (Traditional)
- Applicant: Ams Co., Ltd.
- Decided: Mar 12, 2010 after 114 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: 7 generations back to K830955 (1983). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083201: Zmatch Block, Dentaim Co., Ltd. (2009) Summary page 1.

## Indications for use
Zr Dental block is intended for CAD/CAM fabrication of all ceramic dental restorations. This device is used for manufacturing of inlays, onlays, veneers, crowns and bridges

Source page: https://510kreport.com/device/K093571
Methodology: https://510kreport.com/methodology