FDA 510(k)

Shofu Block HC 硬質

K 號：K200470 · 2021-02-05

決定日期2021-02-05

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Shofu Block HC Hard is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corporation. It received FDA 510(k) clearance on 2021-02-05 under 510(k) number K200470. 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 Shofu Block HC Hard?

Shofu Block HC Hard is a medical device that received FDA 510(k) clearance on 2021-02-05. The listed applicant is Shofu Dental Corporation. The 510(k) number is K200470.

When did Shofu Block HC Hard receive FDA 510(k) clearance?

Shofu Block HC Hard received FDA 510(k) clearance on 2021-02-05, under 510(k) number K200470.

Who is the listed applicant for Shofu Block HC Hard?

The FDA 510(k) record lists Shofu Dental Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Shofu Block HC Hard?

The FDA product code for Shofu Block HC Hard is EBF.

其他以 Shofu Dental Corporation 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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