FDA 510(k)

Diafil & Diafil Capsule

K号: K210421 · 2021-06-28

决定日期2021-06-28

产品代码EBF

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决定实质等同

器械摘要

Diafil & Diafil Capsule 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 2021-06-28 under 510(k) number K210421. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Diafil & Diafil Capsule?

Diafil & Diafil Capsule is a medical device that received FDA 510(k) clearance on 2021-06-28. The listed applicant is DiaDent Group International. The 510(k) number is K210421.

When did Diafil & Diafil Capsule receive FDA 510(k) clearance?

Diafil & Diafil Capsule received FDA 510(k) clearance on 2021-06-28, under 510(k) number K210421.

Who is the listed applicant for Diafil & Diafil Capsule?

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 Diafil & Diafil Capsule?

The FDA product code for Diafil & Diafil Capsule is EBF.

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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