# K190436: KATANA Zirconia Block

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: May 23, 2019 after 90 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 K170986 (2017). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170986: KATANA Zirconia Block, Kuraray Noritake Dental, Inc. (2017) Summary page 4.

## Most influential descendants
- K242462: CEREC Cercon 4D CAD/CAM Blocks (2024), 0 descendants of its own

## Indications for use
KATANA Zirconia Block is used for the fabrication of the ceramic restorations (frameworks, FCZ crowns, FCZ bridges (14Z L only), inlays, onlays and veneers).

Source page: https://510kreport.com/device/K190436
Methodology: https://510kreport.com/methodology