FDA 510(k)

瓷美 Zolid HT+ 白色

K 號：K171876 · 2017-09-20

決定日期2017-09-20

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

Ceramill Zolid HT+ white is the device name listed in this FDA 510(k) record. The listed applicant is Amann Girrbach AG. It received FDA 510(k) clearance on 2017-09-20 under 510(k) number K171876. 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 Ceramill Zolid HT+ white?

Ceramill Zolid HT+ white is a medical device that received FDA 510(k) clearance on 2017-09-20. The listed applicant is Amann Girrbach AG. The 510(k) number is K171876.

When did Ceramill Zolid HT+ white receive FDA 510(k) clearance?

Ceramill Zolid HT+ white received FDA 510(k) clearance on 2017-09-20, under 510(k) number K171876.

Who is the listed applicant for Ceramill Zolid HT+ white?

The FDA 510(k) record lists Amann Girrbach AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ceramill Zolid HT+ white?

The FDA product code for Ceramill Zolid HT+ white is EIH.

其他以 Amann Girrbach AG 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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