FDA 510(k)

EDS大眾水泥

K 號：K152691 · 2016-02-25

決定日期2016-02-25

產品代碼EMA

諮詢委員會DE

決定相當於

器材摘要

EDS Universal Cement is the device name listed in this FDA 510(k) record. The listed applicant is Essential Dental Systems, Inc.. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K152691. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EDS Universal Cement?

EDS Universal Cement is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Essential Dental Systems, Inc.. The 510(k) number is K152691.

When did EDS Universal Cement receive FDA 510(k) clearance?

EDS Universal Cement received FDA 510(k) clearance on 2016-02-25, under 510(k) number K152691.

Who is the listed applicant for EDS Universal Cement?

The FDA 510(k) record lists Essential Dental Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EDS Universal Cement?

The FDA product code for EDS Universal Cement is EMA.

其他以 Essential Dental Systems, Inc. 為申請人之記錄

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K223340EDS 鈣鹼軟化器 TURBO CR

相關器械（代碼：EMA）

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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官方來源

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