Endocem MTA 預混標準型
K 號：K213757 · 2023-02-14
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器材摘要
Endocem MTA Premixed Regular is the device name listed in this FDA 510(k) record. The listed applicant is Maruchi. It received FDA 510(k) clearance on 2023-02-14 under 510(k) number K213757. 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 Endocem MTA Premixed Regular?
Endocem MTA Premixed Regular is a medical device that received FDA 510(k) clearance on 2023-02-14. The listed applicant is Maruchi. The 510(k) number is K213757.
When did Endocem MTA Premixed Regular receive FDA 510(k) clearance?
Endocem MTA Premixed Regular received FDA 510(k) clearance on 2023-02-14, under 510(k) number K213757.
Who is the listed applicant for Endocem MTA Premixed Regular?
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 Endocem MTA Premixed Regular?
The FDA product code for Endocem MTA Premixed Regular is KIF.
相關臨床試驗
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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。
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。
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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