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510(k) Data Aggregation

    K Number
    K053099
    Device Name
    BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS, INC.
    Date Cleared
    2006-02-14

    (103 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K050208,K051717
    Predicate For
    K122559
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BioHorizons Plastic Temporary Abutments are intended for short-term use of 30 days or less as a base for cemented or screw-retained crown and bridge restoration of dental implants, while esthetically contouring soft tissue.

    Device Description

    BioHorizons Plastic Temporary Abutments are medical grade machined polyetheretherketone (PEEK) material, supplied sterile using gamma radiation for use as short-term (30 days or less) restorative dental implant abutments.

    AI/ML Overview

    I'm sorry, but an acceptance criteria table and details about a study on device performance, including information about sample sizes, expert involvement, and ground truth establishment, are not present in the provided text. The document is a 510(k) summary for a dental device, focusing on its substantial equivalence to predicate devices based on design, material, and intended use, rather than a clinical performance study with defined acceptance criteria.

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