Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Neodent InLab Validated Workflow

K-Number: K252727 · 2026-01-07

ApplicantJJGC Indústria e Comércio de Materiais Dentários S.A.
Decision Date2026-01-07
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neodent InLab Validated Workflow is the device name listed in this FDA 510(k) record. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. It received FDA 510(k) clearance on 2026-01-07 under 510(k) number K252727. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neodent InLab Validated Workflow?

Neodent InLab Validated Workflow is a medical device that received FDA 510(k) clearance on 2026-01-07. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. The 510(k) number is K252727.

When did Neodent InLab Validated Workflow receive FDA 510(k) clearance?

Neodent InLab Validated Workflow received FDA 510(k) clearance on 2026-01-07, under 510(k) number K252727.

Who is the listed applicant for Neodent InLab Validated Workflow?

The FDA 510(k) record lists JJGC Indústria e Comércio de Materiais Dentários S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neodent InLab Validated Workflow?

The FDA product code for Neodent InLab Validated Workflow is NHA.

Other records listing JJGC Indústria e Comércio de Materiais Dentários S.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261147Neodent Implant System - NeoConvert FitK253922Neodent Scannable Healing AbutmentK252090Pterygoid Indication for GM Helix ImplantsK250271Neodent Implant System - Zirconia Implant SystemK241492Guided Surgery Kit CasesK233857Neodent Implant System – Custom Abutments

View all 12 devices →

Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑