FDA 510(k)

牙醫氧化鋁陶瓷

K 號：K213570 · 2022-01-07

申請人Aidite (Qinhuangdao) Technology Co., Ltd.

決定日期2022-01-07

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

Dental Zirconia Ceramic is the device name listed in this FDA 510(k) record. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K213570. 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 Dental Zirconia Ceramic?

Dental Zirconia Ceramic is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K213570.

When did Dental Zirconia Ceramic receive FDA 510(k) clearance?

Dental Zirconia Ceramic received FDA 510(k) clearance on 2022-01-07, under 510(k) number K213570.

Who is the listed applicant for Dental Zirconia Ceramic?

The FDA 510(k) record lists Aidite (Qinhuangdao) Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Zirconia Ceramic?

The FDA product code for Dental Zirconia Ceramic is EIH.

其他以 Aidite (Qinhuangdao) Technology Co., Ltd. 為申請人之記錄

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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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