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FDA 510(k)

ZENEX FreeMilling & CCM Cast Abutment

K-Number: K231557 · 2023-08-24

ApplicantIzenimplant Co., Ltd.
Decision Date2023-08-24
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZENEX FreeMilling & CCM Cast Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Izenimplant Co., Ltd.. It received FDA 510(k) clearance on 2023-08-24 under 510(k) number K231557. 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 ZENEX FreeMilling & CCM Cast Abutment?

ZENEX FreeMilling & CCM Cast Abutment is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is Izenimplant Co., Ltd.. The 510(k) number is K231557.

When did ZENEX FreeMilling & CCM Cast Abutment receive FDA 510(k) clearance?

ZENEX FreeMilling & CCM Cast Abutment received FDA 510(k) clearance on 2023-08-24, under 510(k) number K231557.

Who is the listed applicant for ZENEX FreeMilling & CCM Cast Abutment?

The FDA 510(k) record lists Izenimplant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZENEX FreeMilling & CCM Cast Abutment?

The FDA product code for ZENEX FreeMilling & CCM Cast Abutment is NHA.

Other records listing Izenimplant Co., Ltd. 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.

K253334ZENEX Implant System_Short (R-System)K252585ZENEX Implant System_R-SystemK240560ZENEX Implant System_LongK232170Ti Link AbutmentK233163ZENEX Implant System_ShortK230630ZENEX Implant System_Narrow

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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.

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