# K131534: Katana Zirconia

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Oct 11, 2013 after 135 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
KATANA Zircanla Is used far fabricating the all-cemamic dental frameworks or FCZ crowns and bridges. This disc (or block) is designed to provide patients with strong and tough prosthetic dental restorations for anterior and posterior applications.

Source page: https://510kreport.com/device/K131534
Methodology: https://510kreport.com/methodology