FDA 510(k)

NUVO CF 种植系统

K号: K203309 · 2021-07-06

申请人JJGC Indústria e Comércio de Materiais Dentários S.A.

决定日期2021-07-06

产品代码DZE

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决定实质等同

器械摘要

NUVO CF Implant System is the device name listed in this FDA 510(k) record. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. It received FDA 510(k) clearance on 2021-07-06 under 510(k) number K203309. 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 NUVO CF Implant System?

NUVO CF Implant System is a medical device that received FDA 510(k) clearance on 2021-07-06. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. The 510(k) number is K203309.

When did NUVO CF Implant System receive FDA 510(k) clearance?

NUVO CF Implant System received FDA 510(k) clearance on 2021-07-06, under 510(k) number K203309.

Who is the listed applicant for NUVO CF Implant System?

The FDA 510(k) record lists JJGC Indústria e Comércio de Materiais Dentários S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NUVO CF Implant System?

The FDA product code for NUVO CF Implant System is DZE.

列明JJGC Indústria e Comércio de Materiais Dentários S.A.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。

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