FDA 510(k)

Noris Medical牙科植入系统 - Cortical

K号: K210852 · 2022-06-24

决定日期2022-06-24

产品代码DZE

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

Noris Medical Dental Implants System - Cortical is the device name listed in this FDA 510(k) record. The listed applicant is Noris Medical , Ltd.. It received FDA 510(k) clearance on 2022-06-24 under 510(k) number K210852. 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 Noris Medical Dental Implants System - Cortical?

Noris Medical Dental Implants System - Cortical is a medical device that received FDA 510(k) clearance on 2022-06-24. The listed applicant is Noris Medical , Ltd.. The 510(k) number is K210852.

When did Noris Medical Dental Implants System - Cortical receive FDA 510(k) clearance?

Noris Medical Dental Implants System - Cortical received FDA 510(k) clearance on 2022-06-24, under 510(k) number K210852.

Who is the listed applicant for Noris Medical Dental Implants System - Cortical?

The FDA 510(k) record lists Noris Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Noris Medical Dental Implants System - Cortical?

The FDA product code for Noris Medical Dental Implants System - Cortical is DZE.

列明Noris Medical , 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。

K241462LONGY Implant and LONGY-N Implant K240202锥形平台牙种植系统 K210356Noris Medical牙科植入系统 K162308Noris Medical MBI-2mm牙科植入系统 K153043Noris Medical MBI牙科植入系统 K151909Noris Medical颧骨牙科植入系统

查看所有 7 个设备 →

官方来源

在 FDA 数据库中查看 →

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。