FDA 510(k)

彈性塊

K 號：K213994 · 2022-03-04

申請人Shandong Huge Dental Material Corporation

決定日期2022-03-04

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

Flexible Block is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Huge Dental Material Corporation. It received FDA 510(k) clearance on 2022-03-04 under 510(k) number K213994. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Flexible Block?

Flexible Block is a medical device that received FDA 510(k) clearance on 2022-03-04. The listed applicant is Shandong Huge Dental Material Corporation. The 510(k) number is K213994.

When did Flexible Block receive FDA 510(k) clearance?

Flexible Block received FDA 510(k) clearance on 2022-03-04, under 510(k) number K213994.

Who is the listed applicant for Flexible Block?

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

What is the FDA product code for Flexible Block?

The FDA product code for Flexible Block is EBI.

其他以 Shandong Huge Dental Material Corporation 為申請人之記錄

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相關器械（代碼：EBI）

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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