FDA 510(k)

UF(II) 棒座承托體

K 號：K193404 · 2020-05-18

決定日期2020-05-18

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

UF(II) Bar holder 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 2020-05-18 under 510(k) number K193404. 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 UF(II) Bar holder abutment?

UF(II) Bar holder abutment is a medical device that received FDA 510(k) clearance on 2020-05-18. The listed applicant is Dio Corporation. The 510(k) number is K193404.

When did UF(II) Bar holder abutment receive FDA 510(k) clearance?

UF(II) Bar holder abutment received FDA 510(k) clearance on 2020-05-18, under 510(k) number K193404.

Who is the listed applicant for UF(II) Bar holder 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 UF(II) Bar holder abutment?

The FDA product code for UF(II) Bar holder abutment is NHA.

其他以 Dio Corporation 為申請人之記錄

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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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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