FDA 510(k)

Dia-X Bond Universal

K号: K220804 · 2022-06-15

决定日期2022-06-15

产品代码KLE

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决定实质等同

器械摘要

Dia-X Bond Universal 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 2022-06-15 under 510(k) number K220804. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dia-X Bond Universal?

Dia-X Bond Universal is a medical device that received FDA 510(k) clearance on 2022-06-15. The listed applicant is DiaDent Group International. The 510(k) number is K220804.

When did Dia-X Bond Universal receive FDA 510(k) clearance?

Dia-X Bond Universal received FDA 510(k) clearance on 2022-06-15, under 510(k) number K220804.

Who is the listed applicant for Dia-X Bond Universal?

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-X Bond Universal?

The FDA product code for Dia-X Bond Universal is KLE.

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。

K254152Dia-X Sil Light Body K254142迪亚-X 硅重体 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。