FDA 510(k)

BEAUTIFIL II LS

K 號：K160596 · 2016-07-27

決定日期2016-07-27

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

BEAUTIFIL II LS 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 2016-07-27 under 510(k) number K160596. 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 BEAUTIFIL II LS?

BEAUTIFIL II LS is a medical device that received FDA 510(k) clearance on 2016-07-27. The listed applicant is Shofu Dental Corporation. The 510(k) number is K160596.

When did BEAUTIFIL II LS receive FDA 510(k) clearance?

BEAUTIFIL II LS received FDA 510(k) clearance on 2016-07-27, under 510(k) number K160596.

Who is the listed applicant for BEAUTIFIL II LS?

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 BEAUTIFIL II LS?

The FDA product code for BEAUTIFIL II LS 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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