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FDA 510(k)

Cortex CAD/CAM Abutments

K-Number: K181580 · 2019-01-29

ApplicantCortex Dental Implants Industries , Ltd.
Decision Date2019-01-29
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Cortex CAD/CAM Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Cortex Dental Implants Industries , Ltd.. It received FDA 510(k) clearance on 2019-01-29 under 510(k) number K181580. 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 Cortex CAD/CAM Abutments?

Cortex CAD/CAM Abutments is a medical device that received FDA 510(k) clearance on 2019-01-29. The listed applicant is Cortex Dental Implants Industries , Ltd.. The 510(k) number is K181580.

When did Cortex CAD/CAM Abutments receive FDA 510(k) clearance?

Cortex CAD/CAM Abutments received FDA 510(k) clearance on 2019-01-29, under 510(k) number K181580.

Who is the listed applicant for Cortex CAD/CAM Abutments?

The FDA 510(k) record lists Cortex Dental Implants Industries , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cortex CAD/CAM Abutments?

The FDA product code for Cortex CAD/CAM Abutments is NHA.

Other records listing Cortex Dental Implants Industries , 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.

K163385Cortex Dental 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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