BracePaste 銀鹹封口劑
K 號：K242537 · 2024-08-27
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器材摘要
BracePaste Fluoride Sealant is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics Corp.. It received FDA 510(k) clearance on 2024-08-27 under 510(k) number K242537. 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 Fluoride Sealant?
BracePaste Fluoride Sealant is a medical device that received FDA 510(k) clearance on 2024-08-27. The listed applicant is American Orthodontics Corp.. The 510(k) number is K242537.
When did BracePaste Fluoride Sealant receive FDA 510(k) clearance?
BracePaste Fluoride Sealant received FDA 510(k) clearance on 2024-08-27, under 510(k) number K242537.
Who is the listed applicant for BracePaste Fluoride Sealant?
The FDA 510(k) record lists American Orthodontics Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BracePaste Fluoride Sealant?
The FDA product code for BracePaste Fluoride Sealant is DYH.
相關臨床試驗
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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 OrthodonticsK250015Ormco™ EtchFree 粘合系統，Ormco™ EtchFree 粘合底漆，Ormco™ EtchFree 黏合劑Ormco CorporationK2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic ProductsK231817AlignerFlow LCVoco GmbHK214054TP 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。
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