FDA 510(k)

翼状突起用于GM螺旋植入物

K号: K252090 · 2025-12-12

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

决定日期2025-12-12

产品代码DZE

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决定实质等同

器械摘要

Pterygoid Indication for GM Helix Implants 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 2025-12-12 under 510(k) number K252090. 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 Pterygoid Indication for GM Helix Implants?

Pterygoid Indication for GM Helix Implants is a medical device that received FDA 510(k) clearance on 2025-12-12. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. The 510(k) number is K252090.

When did Pterygoid Indication for GM Helix Implants receive FDA 510(k) clearance?

Pterygoid Indication for GM Helix Implants received FDA 510(k) clearance on 2025-12-12, under 510(k) number K252090.

Who is the listed applicant for Pterygoid Indication for GM Helix Implants?

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 Pterygoid Indication for GM Helix Implants?

The FDA product code for Pterygoid Indication for GM Helix Implants 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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