FDA 510(k)

KATANA氧化锆板

K号: K190436 · 2019-05-23

决定日期2019-05-23

产品代码EIH

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决定实质等同

器械摘要

KATANA Zirconia Block is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2019-05-23 under 510(k) number K190436. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the KATANA Zirconia Block?

KATANA Zirconia Block is a medical device that received FDA 510(k) clearance on 2019-05-23. The listed applicant is Kuraray Noritake Dental, Inc.. The 510(k) number is K190436.

When did KATANA Zirconia Block receive FDA 510(k) clearance?

KATANA Zirconia Block received FDA 510(k) clearance on 2019-05-23, under 510(k) number K190436.

Who is the listed applicant for KATANA Zirconia Block?

The FDA 510(k) record lists Kuraray Noritake Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KATANA Zirconia Block?

The FDA product code for KATANA Zirconia Block is EIH.

列明Kuraray Noritake Dental, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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