FDA 510(k)

Neodent Implant System - GM Helix Implants 7.0

K号: K201225 · 2020-09-04

申请人Jjgc Industria E Comercio DE Materiais Dentarios S.A.

决定日期2020-09-04

产品代码DZE

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决定实质等同

器械摘要

Neodent Implant System - GM Helix Implants 7.0 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 2020-09-04 under 510(k) number K201225. 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 - GM Helix Implants 7.0?

Neodent Implant System - GM Helix Implants 7.0 is a medical device that received FDA 510(k) clearance on 2020-09-04. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K201225.

When did Neodent Implant System - GM Helix Implants 7.0 receive FDA 510(k) clearance?

Neodent Implant System - GM Helix Implants 7.0 received FDA 510(k) clearance on 2020-09-04, under 510(k) number K201225.

Who is the listed applicant for Neodent Implant System - GM Helix Implants 7.0?

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 - GM Helix Implants 7.0?

The FDA product code for Neodent Implant System - GM Helix Implants 7.0 is DZE.

列明Jjgc Industria E Comercio DE Materiais Dentarios 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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