白色封闭剂 MTA
K号: K212229 · 2021-08-13
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申请人Maruchi
决定日期2021-08-13
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
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 2021-08-13 under 510(k) number K212229. 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 White Endoseal MTA?
White Endoseal MTA is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Maruchi. The 510(k) number is K212229.
When did White Endoseal MTA receive FDA 510(k) clearance?
White Endoseal MTA received FDA 510(k) clearance on 2021-08-13, under 510(k) number K212229.
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.
相关临床试验
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列明Maruchi为申报人的其他记录
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。
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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