Cleared Traditional

Neodent InLab Validated Workflow

K252727 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Dental

Jan 2026

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K252727 is an FDA 510(k) clearance for the Neodent InLab Validated Workflow, 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 January 7, 2026, 132 days after receiving the submission on August 28, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K252727 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2025
Decision Date	January 07, 2026
Days to Decision	132 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.