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FDA 510(k)

Pterygoid Indication for GM Helix Implants

K-Number: K252090 · 2025-12-12

ApplicantJJGC Indústria e Comércio de Materiais Dentários S.A.
Decision Date2025-12-12
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Pterygoid Indication for GM Helix Implants is a medical device manufactured by JJGC Indústria e Comércio de Materiais Dentários S.A.. It received FDA 510(k) clearance on 2025-12-12 under approval number K252090. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by JJGC Indústria e Comércio de Materiais Dentários S.A.. The 510(k) number is K252090.

When was Pterygoid Indication for GM Helix Implants approved by the FDA?

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

What company makes Pterygoid Indication for GM Helix Implants?

Pterygoid Indication for GM Helix Implants is manufactured by JJGC Indústria e Comércio de Materiais Dentários S.A..

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.

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Other Devices by JJGC Indústria e Comércio de Materiais Dentários S.A.

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Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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