FDA 510(k)

白 ENDOSEAL MTA

K 號：K202015 · 2021-03-24

決定日期2021-03-24

產品代碼KIF

諮詢委員會DE

決定相當於

器材摘要

White ENDOSEAL MTA is the device name listed in this FDA 510(k) record. The listed applicant is Maruchi. It received FDA 510(k) clearance on 2021-03-24 under 510(k) number K202015. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the White ENDOSEAL MTA?

White ENDOSEAL MTA is a medical device that received FDA 510(k) clearance on 2021-03-24. The listed applicant is Maruchi. The 510(k) number is K202015.

When did White ENDOSEAL MTA receive FDA 510(k) clearance?

White ENDOSEAL MTA received FDA 510(k) clearance on 2021-03-24, under 510(k) number K202015.

Who is the listed applicant for White ENDOSEAL MTA?

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

What is the FDA product code for White ENDOSEAL MTA?

The FDA product code for White ENDOSEAL MTA is KIF.

其他以 Maruchi 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。

K213757Endocem MTA 預混標準型 K212229白端封釋MTA K201799清潔凈化器 K170175ENDOSEAL MTA

相關器械（代碼：KIF）

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。

K262050Vioseal XSpident Co., Ltd.K253909NeoPEX™ 預混充填膠NuSmile, Ltd.K261514鈣氫氧化臨時填充材質（KP-Cal）Guilin Kevin Peter Technology Co., Ltd.K261415注射式根管封閉劑（KP-Root SP）Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation

官方來源

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