FDA 510(k)

CERABIEN ZR

K号: K170834 · 2017-10-17

决定日期2017-10-17

产品代码EIH

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决定实质等同

器械摘要

CERABIEN ZR 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 2017-10-17 under 510(k) number K170834. 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 CERABIEN ZR?

CERABIEN ZR is a medical device that received FDA 510(k) clearance on 2017-10-17. The listed applicant is Kuraray Noritake Dental, Inc.. The 510(k) number is K170834.

When did CERABIEN ZR receive FDA 510(k) clearance?

CERABIEN ZR received FDA 510(k) clearance on 2017-10-17, under 510(k) number K170834.

Who is the listed applicant for CERABIEN ZR?

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 CERABIEN ZR?

The FDA product code for CERABIEN ZR 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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