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FDA 510(k)

Dynax透明,Dynax膠泥,Dynax重質地,Dynax輕質地,Dynax單色

K 號:K171562 · 2018-04-13

決定日期2018-04-13
產品代碼ELW
諮詢委員會DE
決定相當於

器材摘要

Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono is the device name listed in this FDA 510(k) record. The listed applicant is Dreve Dentamid GmbH. It received FDA 510(k) clearance on 2018-04-13 under 510(k) number K171562. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono?

Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono is a medical device that received FDA 510(k) clearance on 2018-04-13. The listed applicant is Dreve Dentamid GmbH. The 510(k) number is K171562.

When did Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono receive FDA 510(k) clearance?

Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono received FDA 510(k) clearance on 2018-04-13, under 510(k) number K171562.

Who is the listed applicant for Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono?

The FDA 510(k) record lists Dreve Dentamid GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono?

The FDA product code for Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono is ELW.

相關臨床試驗

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其他以 Dreve Dentamid GmbH 為申請人之記錄

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相關器械(代碼:ELW)

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。

官方來源

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