FDA 510(k)

Neodent Implant System-Helix NGM Compact Surgical Kit Cases

K号: K214051 · 2022-04-13

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

决定日期2022-04-13

产品代码KCT

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Neodent Implant System-Helix NGM Compact Surgical Kit Cases 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 2022-04-13 under 510(k) number K214051. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Neodent Implant System-Helix NGM Compact Surgical Kit Cases?

Neodent Implant System-Helix NGM Compact Surgical Kit Cases is a medical device that received FDA 510(k) clearance on 2022-04-13. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. The 510(k) number is K214051.

When did Neodent Implant System-Helix NGM Compact Surgical Kit Cases receive FDA 510(k) clearance?

Neodent Implant System-Helix NGM Compact Surgical Kit Cases received FDA 510(k) clearance on 2022-04-13, under 510(k) number K214051.

Who is the listed applicant for Neodent Implant System-Helix NGM Compact Surgical Kit Cases?

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 Neodent Implant System-Helix NGM Compact Surgical Kit Cases?

The FDA product code for Neodent Implant System-Helix NGM Compact Surgical Kit Cases is KCT.

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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