FDA 510(k)

BracePaste 腰帶及建構系統

K 號：K202276 · 2020-08-14

決定日期2020-08-14

產品代碼DYH

諮詢委員會DE

決定相當於

器材摘要

BracePaste Band and Build LC is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 2020-08-14 under 510(k) number K202276. 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 BracePaste Band and Build LC?

BracePaste Band and Build LC is a medical device that received FDA 510(k) clearance on 2020-08-14. The listed applicant is American Orthodontics. The 510(k) number is K202276.

When did BracePaste Band and Build LC receive FDA 510(k) clearance?

BracePaste Band and Build LC received FDA 510(k) clearance on 2020-08-14, under 510(k) number K202276.

Who is the listed applicant for BracePaste Band and Build LC?

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

What is the FDA product code for BracePaste Band and Build LC?

The FDA product code for BracePaste Band and Build LC is DYH.

其他以 American Orthodontics 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。

K261840BracePaste Prime Plus K232011Cleo K181910BracePaste MTP 光固化底漆 K172953酸蝕劑 K160782BracePaste膠帶

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

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