FDA 510(k)

UniFit 牙齿种植系统

K号: K223714 · 2023-12-29

决定日期2023-12-29

产品代码DZE

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决定实质等同

器械摘要

UniFit Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Adin Dental Implant Systems , Ltd.. It received FDA 510(k) clearance on 2023-12-29 under 510(k) number K223714. 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 UniFit Dental Implant System?

UniFit Dental Implant System is a medical device that received FDA 510(k) clearance on 2023-12-29. The listed applicant is Adin Dental Implant Systems , Ltd.. The 510(k) number is K223714.

When did UniFit Dental Implant System receive FDA 510(k) clearance?

UniFit Dental Implant System received FDA 510(k) clearance on 2023-12-29, under 510(k) number K223714.

Who is the listed applicant for UniFit Dental Implant System?

The FDA 510(k) record lists Adin Dental Implant Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UniFit Dental Implant System?

The FDA product code for UniFit Dental Implant System is DZE.

列明Adin Dental Implant Systems , 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。

K252031Adin Long Dental Implant System K250178Adin Customized Abutments

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。