FDA 510(k)

DIO CAD/CAM 牙槽橋

K 號：K181037 · 2018-12-21

決定日期2018-12-21

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

DIO CAD/CAM Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Dio Corporation. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K181037. 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 DIO CAD/CAM Abutment?

DIO CAD/CAM Abutment is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Dio Corporation. The 510(k) number is K181037.

When did DIO CAD/CAM Abutment receive FDA 510(k) clearance?

DIO CAD/CAM Abutment received FDA 510(k) clearance on 2018-12-21, under 510(k) number K181037.

Who is the listed applicant for DIO CAD/CAM Abutment?

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

What is the FDA product code for DIO CAD/CAM Abutment?

The FDA product code for DIO CAD/CAM Abutment is NHA.

其他以 Dio 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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