Endocem MTA Premixed Regular
K号: K213757 · 2023-02-14
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申请人Maruchi
决定日期2023-02-14
产品代码KIF
咨询委员会DE
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决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
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列明Maruchi为申报人的其他记录
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相关器械（代码：KIF）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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