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FDA 510(k)

Duranext 牙槽橋

K 號:K200355 · 2020-07-22

決定日期2020-07-22
產品代碼NHA
諮詢委員會DE
決定相當於

器材摘要

Duranext Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Elegant Dental Corp.. It received FDA 510(k) clearance on 2020-07-22 under 510(k) number K200355. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Duranext Abutments?

Duranext Abutments is a medical device that received FDA 510(k) clearance on 2020-07-22. The listed applicant is Elegant Dental Corp.. The 510(k) number is K200355.

When did Duranext Abutments receive FDA 510(k) clearance?

Duranext Abutments received FDA 510(k) clearance on 2020-07-22, under 510(k) number K200355.

Who is the listed applicant for Duranext Abutments?

The FDA 510(k) record lists Elegant Dental Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Duranext Abutments?

The FDA product code for Duranext Abutments is NHA.

相關臨床試驗

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相關器械(代碼:NHA)

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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