Biodentine XP 500，Biodentine XP 200
K号: K211799 · 2021-08-10
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申请人Septodont
决定日期2021-08-10
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
Biodentine XP 500, Biodentine XP 200 is the device name listed in this FDA 510(k) record. The listed applicant is Septodont. It received FDA 510(k) clearance on 2021-08-10 under 510(k) number K211799. 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 Biodentine XP 500, Biodentine XP 200?
Biodentine XP 500, Biodentine XP 200 is a medical device that received FDA 510(k) clearance on 2021-08-10. The listed applicant is Septodont. The 510(k) number is K211799.
When did Biodentine XP 500, Biodentine XP 200 receive FDA 510(k) clearance?
Biodentine XP 500, Biodentine XP 200 received FDA 510(k) clearance on 2021-08-10, under 510(k) number K211799.
Who is the listed applicant for Biodentine XP 500, Biodentine XP 200?
The FDA 510(k) record lists Septodont as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Biodentine XP 500, Biodentine XP 200?
The FDA product code for Biodentine XP 500, Biodentine XP 200 is KIF.
相关临床试验
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列明Septodont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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