FDA 510(k)

STERI-OSS植入系统

K号: K232268 · 2024-03-25

决定日期2024-03-25

产品代码DZE

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决定实质等同

器械摘要

STERI-OSS Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Zeros Co., Ltd.. It received FDA 510(k) clearance on 2024-03-25 under 510(k) number K232268. 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 STERI-OSS Implant System?

STERI-OSS Implant System is a medical device that received FDA 510(k) clearance on 2024-03-25. The listed applicant is Zeros Co., Ltd.. The 510(k) number is K232268.

When did STERI-OSS Implant System receive FDA 510(k) clearance?

STERI-OSS Implant System received FDA 510(k) clearance on 2024-03-25, under 510(k) number K232268.

Who is the listed applicant for STERI-OSS Implant System?

FDA 510(k)记录将Zeros 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 STERI-OSS Implant System?

The FDA product code for STERI-OSS Implant System is DZE.

列明Zeros 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。

K260463ZEROS 牙齿种植系统

官方来源

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