FDA 510(k)

DIOnavi-假牙02

K 號：K210828 · 2021-03-23

決定日期2021-03-23

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

DIOnavi-Denture02 is the device name listed in this FDA 510(k) record. The listed applicant is Dio Corporation. It received FDA 510(k) clearance on 2021-03-23 under 510(k) number K210828. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DIOnavi-Denture02?

DIOnavi-Denture02 is a medical device that received FDA 510(k) clearance on 2021-03-23. The listed applicant is Dio Corporation. The 510(k) number is K210828.

When did DIOnavi-Denture02 receive FDA 510(k) clearance?

DIOnavi-Denture02 received FDA 510(k) clearance on 2021-03-23, under 510(k) number K210828.

Who is the listed applicant for DIOnavi-Denture02?

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 DIOnavi-Denture02?

The FDA product code for DIOnavi-Denture02 is EBI.

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。

K220253Eco 牙槽，多單元牙槽 K193623DIOnavi-假牙 K193404UF(II) 棒座承托體 K192263UCLA CCM 牙槽橋 K190048UF(II) 適用解剖式牙根擴張體 K181037DIO CAD/CAM 牙槽橋

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相關器械（代碼：EBI）

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。

K261802Glidewell™ 牙托基材膠Prismatik Dentalcraft, Inc.K261626超印柔軟假牙紫外線Guangzhou Heygears IMC., Inc.K262681奈米瓷膠膠黏劑3BFAB TEKNOLOJI A.S.K262300假牙基座膠 V2Formlabs Ohio, Inc.K261474DENTCA 真柔軟Dentca, Inc.K260569DB 4000 高衝擊牙托基座Carbon, Inc.

官方來源

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