Cleared Traditional

Pterygoid Indication for GM Helix Implants

K252090 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Dental
Dec 2025
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K252090 is an FDA 510(k) clearance for the Pterygoid Indication for GM Helix Implants, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. (Curitiba, BR). The FDA issued a Cleared decision on December 12, 2025, 163 days after receiving the submission on July 2, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K252090 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2025
Decision Date December 12, 2025
Days to Decision 163 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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