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510(k) Data Aggregation

    K Number
    K160581
    Device Name
    K3PRO Konus Additional Abutments and Implants
    Manufacturer
    ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG
    Date Cleared
    2017-03-24

    (388 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    K3PRO Konus Additional Abutments and Implants

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    K3Pro Konus Additional Abutments and Implants are designed to be compatible with the K3Pro Konus Dental Implant system and are for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial dentures, or as a single tooth replacement. Delayed loading is recommended. The prosthesis may be secured to the abutment by the use of adhesives or mechanically by the use of a screw.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) Clearance letter from the FDA for a dental implant system. It does not contain any information about a study that proves a device meets acceptance criteria, an AI/ML powered device, or any performance metrics. Therefore, I cannot generate the requested information based on the input.

    The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance, rather than requiring performance data against specific acceptance criteria as would be needed for a novel device or AI/ML product.

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