Cleared Traditional

Neodent Implant System ? Custom Abutments

K233857 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Dental

May 2024

Decision

149d

Days

Class 2

Risk

About This 510(k) Submission

K233857 is an FDA 510(k) clearance for the Neodent Implant System ? Custom Abutments, 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 May 2, 2024, 149 days after receiving the submission on December 5, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K233857 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 2023
Decision Date	May 02, 2024
Days to Decision	149 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.