FDA 510(k)

ArgenIS 钛金基座

K 號：K172430 · 2018-05-18

決定日期2018-05-18

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

ArgenIS Titanium Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Argen Corporation. It received FDA 510(k) clearance on 2018-05-18 under 510(k) number K172430. 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 ArgenIS Titanium Abutments?

ArgenIS Titanium Abutments is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is Argen Corporation. The 510(k) number is K172430.

When did ArgenIS Titanium Abutments receive FDA 510(k) clearance?

ArgenIS Titanium Abutments received FDA 510(k) clearance on 2018-05-18, under 510(k) number K172430.

Who is the listed applicant for ArgenIS Titanium Abutments?

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

What is the FDA product code for ArgenIS Titanium Abutments?

The FDA product code for ArgenIS Titanium Abutments is NHA.

其他以 Argen Corporation 為申請人之記錄

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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。

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官方來源

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