FDA 510(k)

翼顎植入物GM螺旋體適應症

K 號：K252090 · 2025-12-12

申請人JJGC Indústria e Comércio de Materiais Dentários S.A.

決定日期2025-12-12

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.