FDA 510(k)

UNIdental交响乐种植系统

K号: K221315 · 2023-10-25

决定日期2023-10-25

产品代码DZE

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决定实质等同

器械摘要

UNIdental Symphony Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Unidental Co., Ltd.. It received FDA 510(k) clearance on 2023-10-25 under 510(k) number K221315. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the UNIdental Symphony Implant System?

UNIdental Symphony Implant System is a medical device that received FDA 510(k) clearance on 2023-10-25. The listed applicant is Unidental Co., Ltd.. The 510(k) number is K221315.

When did UNIdental Symphony Implant System receive FDA 510(k) clearance?

UNIdental Symphony Implant System received FDA 510(k) clearance on 2023-10-25, under 510(k) number K221315.

Who is the listed applicant for UNIdental Symphony Implant System?

FDA 510(k)记录将Unidental Co., Ltd.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for UNIdental Symphony Implant System?

The FDA product code for UNIdental Symphony Implant System is DZE.

列明Unidental Co., Ltd.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。

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