FDA 510(k)

牙醫NR線CAD/CAM牙根拋物面

K 號：K170384 · 2017-08-17

決定日期2017-08-17

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Dentium NR Line CAD/CAM Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Dentium Co., Ltd.. It received FDA 510(k) clearance on 2017-08-17 under 510(k) number K170384. 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 Dentium NR Line CAD/CAM Abutments?

Dentium NR Line CAD/CAM Abutments is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Dentium Co., Ltd.. The 510(k) number is K170384.

When did Dentium NR Line CAD/CAM Abutments receive FDA 510(k) clearance?

Dentium NR Line CAD/CAM Abutments received FDA 510(k) clearance on 2017-08-17, under 510(k) number K170384.

Who is the listed applicant for Dentium NR Line CAD/CAM Abutments?

The FDA 510(k) record lists Dentium Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dentium NR Line CAD/CAM Abutments?

The FDA product code for Dentium NR Line CAD/CAM Abutments is NHA.

其他以 Dentium Co., Ltd. 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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