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FDA 510(k)

Neodent Implant System-Easy Pack

K号: K203382 · 2021-03-15

决定日期2021-03-15
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

Neodent Implant System-Easy Pack is the device name listed in this FDA 510(k) record. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It received FDA 510(k) clearance on 2021-03-15 under 510(k) number K203382. 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 Neodent Implant System-Easy Pack?

Neodent Implant System-Easy Pack is a medical device that received FDA 510(k) clearance on 2021-03-15. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K203382.

When did Neodent Implant System-Easy Pack receive FDA 510(k) clearance?

Neodent Implant System-Easy Pack received FDA 510(k) clearance on 2021-03-15, under 510(k) number K203382.

Who is the listed applicant for Neodent Implant System-Easy Pack?

The FDA 510(k) record lists Jjgc Industria E Comercio DE Materiais Dentarios S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neodent Implant System-Easy Pack?

The FDA product code for Neodent Implant System-Easy Pack is DZE.

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列明Jjgc Industria E Comercio DE Materiais Dentarios S.A.为申报人的其他记录

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相关器械(代码:DZE)

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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