FDA 510(k)

CERABIEN ZR

K 號：K170834 · 2017-10-17

決定日期2017-10-17

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

其他以 Kuraray Noritake Dental, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：EIH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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