FDA 510(k)

3M RelyX 優兒童樹脂改進玻璃離子鹽水泥

K 號：K191122 · 2019-05-29

決定日期2019-05-29

產品代碼EMA

諮詢委員會DE

決定相當於

器材摘要

3M RelyX Pediatric Resin Modified Glass Ionomer Cement is the device name listed in this FDA 510(k) record. The listed applicant is 3M Espe Dental Products. It received FDA 510(k) clearance on 2019-05-29 under 510(k) number K191122. 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 3M RelyX Pediatric Resin Modified Glass Ionomer Cement?

3M RelyX Pediatric Resin Modified Glass Ionomer Cement is a medical device that received FDA 510(k) clearance on 2019-05-29. The listed applicant is 3M Espe Dental Products. The 510(k) number is K191122.

When did 3M RelyX Pediatric Resin Modified Glass Ionomer Cement receive FDA 510(k) clearance?

3M RelyX Pediatric Resin Modified Glass Ionomer Cement received FDA 510(k) clearance on 2019-05-29, under 510(k) number K191122.

Who is the listed applicant for 3M RelyX Pediatric Resin Modified Glass Ionomer Cement?

The FDA 510(k) record lists 3M Espe Dental Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M RelyX Pediatric Resin Modified Glass Ionomer Cement?

The FDA product code for 3M RelyX Pediatric Resin Modified Glass Ionomer Cement is EMA.

其他以 3M Espe Dental Products 為申請人之記錄

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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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