FDA 510(k)

Admira Fusion 5

K 號：K230877 · 2023-07-13

決定日期2023-07-13

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Admira Fusion 5 is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2023-07-13 under 510(k) number K230877. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Admira Fusion 5?

Admira Fusion 5 is a medical device that received FDA 510(k) clearance on 2023-07-13. The listed applicant is Voco GmbH. The 510(k) number is K230877.

When did Admira Fusion 5 receive FDA 510(k) clearance?

Admira Fusion 5 received FDA 510(k) clearance on 2023-07-13, under 510(k) number K230877.

Who is the listed applicant for Admira Fusion 5?

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

What is the FDA product code for Admira Fusion 5?

The FDA product code for Admira Fusion 5 is EBF.

其他以 Voco GmbH 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。

K252073VOCO Profluorid Varnish + BioMin K261357大廈多色顯示設備 K252606Bifix Veneer LC, Bifix Veneer 尝試用 K251390MTA vpt K251239GrandioSO無限版 K231817AlignerFlow LC

查看所有 29 項裝置 →

相關器械（代碼：EBF）

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。

K262982Core·it雙用式醫療設備規範文本Spident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695流動性修復材質（KP-Flow LF，KP-Flow MF，KP-Flow HF）Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus 填充劑；Tetric plus 流動劑Ivoclar Vivadent, Inc.K262228超越大量填充濃縮複合材料Ultradent Products, Inc.K261246SRGC-06GC America, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。