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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 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.

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. 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.

Other records listing JJGC Indústria e Comércio de Materiais Dentários S.A. as applicant

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Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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