Cleared Traditional

Neodent Implant System - GM Zygomatic Implant System

K232099 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Dental
Oct 2023
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K232099 is an FDA 510(k) clearance for the Neodent Implant System - GM Zygomatic Implant System, 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 October 31, 2023, 110 days after receiving the submission on July 13, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K232099 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2023
Decision Date October 31, 2023
Days to Decision 110 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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