FDA 510(k)

BrackFix

K 號：K183147 · 2019-03-01

決定日期2019-03-01

產品代碼DYH

諮詢委員會DE

決定相當於

器材摘要

BrackFix is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2019-03-01 under 510(k) number K183147. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BrackFix?

BrackFix is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Voco GmbH. The 510(k) number is K183147.

When did BrackFix receive FDA 510(k) clearance?

BrackFix received FDA 510(k) clearance on 2019-03-01, under 510(k) number K183147.

Who is the listed applicant for BrackFix?

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 BrackFix?

The FDA product code for BrackFix is DYH.

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：DYH）

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。

K261129正適合Spident Co., Ltd.K261840BracePaste Prime PlusAmerican Orthodontics K250015Ormco™ EtchFree 粘合系統，Ormco™ EtchFree 粘合底漆，Ormco™ EtchFree 黏合劑Ormco Corporation K242537BracePaste 銀鹹封口劑American Orthodontics Corp.K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic Products K231817AlignerFlow LCVoco GmbH

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。