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FDA 510(k)

Neodent Implant System - Custom Abutments

K-Number: K250614 · 2025-05-27

ApplicantJjgc Indústria E Comércia DE Materiais Dentários S.A.
Decision Date2025-05-27
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neodent Implant System - Custom Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Jjgc Indústria E Comércia DE Materiais Dentários S.A.. It received FDA 510(k) clearance on 2025-05-27 under 510(k) number K250614. 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 Implant System - Custom Abutments?

Neodent Implant System - Custom Abutments is a medical device that received FDA 510(k) clearance on 2025-05-27. The listed applicant is Jjgc Indústria E Comércia DE Materiais Dentários S.A.. The 510(k) number is K250614.

When did Neodent Implant System - Custom Abutments receive FDA 510(k) clearance?

Neodent Implant System - Custom Abutments received FDA 510(k) clearance on 2025-05-27, under 510(k) number K250614.

Who is the listed applicant for Neodent Implant System - Custom Abutments?

The FDA 510(k) record lists Jjgc Indústria E Comércia 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 Implant System - Custom Abutments?

The FDA product code for Neodent Implant System - Custom Abutments is NHA.

Other records listing Jjgc Indústria E Comércia 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.

K242686Neodent Implant System

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

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

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