FDA 510(k)

Noris Medical MBI牙科植入系统

K号: K153043 · 2016-04-11

决定日期2016-04-11

产品代码DZE

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决定实质等同

器械摘要

Noris Medical MBI Dental Implant System 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 2016-04-11 under 510(k) number K153043. 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 MBI Dental Implant System?

Noris Medical MBI Dental Implant System is a medical device that received FDA 510(k) clearance on 2016-04-11. The listed applicant is Noris Medical , Ltd.. The 510(k) number is K153043.

When did Noris Medical MBI Dental Implant System receive FDA 510(k) clearance?

Noris Medical MBI Dental Implant System received FDA 510(k) clearance on 2016-04-11, under 510(k) number K153043.

Who is the listed applicant for Noris Medical MBI Dental Implant System?

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 MBI Dental Implant System?

The FDA product code for Noris Medical MBI Dental Implant System 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 K210852Noris Medical牙科植入系统 - Cortical K210356Noris Medical牙科植入系统 K162308Noris Medical MBI-2mm牙科植入系统 K151909Noris Medical颧骨牙科植入系统

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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。