SavDenTM MTA 根管填充材料
K号: K162661 · 2017-04-25
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决定日期2017-04-25
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
SavDenTM MTA Root Canal Filling Materials is the device name listed in this FDA 510(k) record. The listed applicant is Tyds Biotech Incorporation. It received FDA 510(k) clearance on 2017-04-25 under 510(k) number K162661. 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 SavDenTM MTA Root Canal Filling Materials?
SavDenTM MTA Root Canal Filling Materials is a medical device that received FDA 510(k) clearance on 2017-04-25. The listed applicant is Tyds Biotech Incorporation. The 510(k) number is K162661.
When did SavDenTM MTA Root Canal Filling Materials receive FDA 510(k) clearance?
SavDenTM MTA Root Canal Filling Materials received FDA 510(k) clearance on 2017-04-25, under 510(k) number K162661.
Who is the listed applicant for SavDenTM MTA Root Canal Filling Materials?
The FDA 510(k) record lists Tyds Biotech Incorporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SavDenTM MTA Root Canal Filling Materials?
The FDA product code for SavDenTM MTA Root Canal Filling Materials is KIF.
相关临床试验
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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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