FDA 510(k)

DIA-ROOT BIO 密封剂

K号: K200175 · 2020-06-25

决定日期2020-06-25

产品代码KIF

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决定实质等同

器械摘要

DIA-ROOT BIO Sealer is the device name listed in this FDA 510(k) record. The listed applicant is DiaDent Group International. It received FDA 510(k) clearance on 2020-06-25 under 510(k) number K200175. 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 DIA-ROOT BIO Sealer?

DIA-ROOT BIO Sealer is a medical device that received FDA 510(k) clearance on 2020-06-25. The listed applicant is DiaDent Group International. The 510(k) number is K200175.

When did DIA-ROOT BIO Sealer receive FDA 510(k) clearance?

DIA-ROOT BIO Sealer received FDA 510(k) clearance on 2020-06-25, under 510(k) number K200175.

Who is the listed applicant for DIA-ROOT BIO Sealer?

FDA 510(k)记录显示DiaDent Group International为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for DIA-ROOT BIO Sealer?

The FDA product code for DIA-ROOT BIO Sealer is KIF.

列明DiaDent Group International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。

K254142迪亚-X 硅重体 K254152Dia-X Sil Light Body K261166DIA-CEM K261093DIAFIL K261071DIAFIL 大量流动（经济包装）；DIAFIL 大量流动（补充包装）；DIAFIL 大量流动（0.5g）K254112Dia-X Sil Bite

查看所有 23 个设备 →

官方来源

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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。