FDA 510(k)

玻璃離子水泥（粘合劑）

K 號：K161851 · 2016-10-31

申請人Shandong Huge Dental Material Corporation

決定日期2016-10-31

產品代碼EMA

諮詢委員會DE

決定相當於

器材摘要

Glass Ionomer Cement (Luting) 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 2016-10-31 under 510(k) number K161851. 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 Glass Ionomer Cement (Luting)?

Glass Ionomer Cement (Luting) is a medical device that received FDA 510(k) clearance on 2016-10-31. The listed applicant is Shandong Huge Dental Material Corporation. The 510(k) number is K161851.

When did Glass Ionomer Cement (Luting) receive FDA 510(k) clearance?

Glass Ionomer Cement (Luting) received FDA 510(k) clearance on 2016-10-31, under 510(k) number K161851.

Who is the listed applicant for Glass Ionomer Cement (Luting)?

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 Glass Ionomer Cement (Luting)?

The FDA product code for Glass Ionomer Cement (Luting) is EMA.

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相關器械（代碼：EMA）

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