Cleared Traditional

Neodent Implant System - Zirconia Implant System

K231803 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Dental

Dec 2023

Decision

176d

Days

Class 2

Risk

About This 510(k) Submission

K231803 is an FDA 510(k) clearance for the Neodent Implant System - Zirconia Implant System, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. (Curitiba, BR). The FDA issued a Cleared decision on December 13, 2023, 176 days after receiving the submission on June 20, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K231803 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2023
Decision Date	December 13, 2023
Days to Decision	176 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NHA — Abutment, Implant, Dental, Endosseous
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3630
Definition	To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.