FDA 510(k)

BracePaste Prime Plus

K 號：K261840 · 2026-06-03

決定日期2026-06-03

產品代碼DYH

諮詢委員會DE

決定相當於

器材摘要

BracePaste Prime Plus is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K261840. 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 Prime Plus?

BracePaste Prime Plus is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is American Orthodontics. The 510(k) number is K261840.

When did BracePaste Prime Plus receive FDA 510(k) clearance?

BracePaste Prime Plus received FDA 510(k) clearance on 2026-06-03, under 510(k) number K261840.

Who is the listed applicant for BracePaste Prime Plus?

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 Prime Plus?

The FDA product code for BracePaste Prime Plus 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。

K232011Cleo K202276BracePaste 腰帶及建構系統 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.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 K214054TP Orthodontics 閃光固化膠粘系統，TP Orthodontics 預應用膠粘劑，TP Orthodontics 酸蝕劑208520Tp Orthodontics, 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。