FDA 510(k)

FiteBac CC 正骨密封

K 號：K210115 · 2021-07-29

決定日期2021-07-29

產品代碼DYH

諮詢委員會DE

決定相當於

器材摘要

FiteBac CC OrthoSeal is the device name listed in this FDA 510(k) record. The listed applicant is Largent Health, LLC. It received FDA 510(k) clearance on 2021-07-29 under 510(k) number K210115. 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 FiteBac CC OrthoSeal?

FiteBac CC OrthoSeal is a medical device that received FDA 510(k) clearance on 2021-07-29. The listed applicant is Largent Health, LLC. The 510(k) number is K210115.

When did FiteBac CC OrthoSeal receive FDA 510(k) clearance?

FiteBac CC OrthoSeal received FDA 510(k) clearance on 2021-07-29, under 510(k) number K210115.

Who is the listed applicant for FiteBac CC OrthoSeal?

The FDA 510(k) record lists Largent Health, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FiteBac CC OrthoSeal?

The FDA product code for FiteBac CC OrthoSeal is DYH.

其他以 Largent Health, LLC 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。

K200614FiteBac 抗菌牙洞清潔劑 K190271FiteBac 腔道清潔劑

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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