FDA 510(k)

牙醫陶瓷塊

K 號：K223742 · 2023-03-08

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

決定日期2023-03-08

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Dental Ceramic Blocks 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 2023-03-08 under 510(k) number K223742. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dental Ceramic Blocks?

Dental Ceramic Blocks is a medical device that received FDA 510(k) clearance on 2023-03-08. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K223742.

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

Dental Ceramic Blocks received FDA 510(k) clearance on 2023-03-08, under 510(k) number K223742.

Who is the listed applicant for Dental Ceramic Blocks?

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 Ceramic Blocks?

The FDA product code for Dental Ceramic Blocks is EBF.

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：EBF）

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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