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510(k) Data Aggregation

    K Number
    K013383
    Device Name
    BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM
    Manufacturer
    BIOMEDICAL IMPLANT TECHNOLOGY, INC.
    Date Cleared
    2002-01-10

    (90 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For implantation into the fully or partially edentulous ridge for the support of a dental prosthesis or for single tooth replacement, in a single stage surgical procedure.

    The product is intended to be implanted with no-load conditions for 8-10 weeks after implantation.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification for a dental implant system. This type of document issues a substantial equivalence determination for a medical device but does not contain acceptance criteria or study results for device performance.

    Therefore, I cannot extract the requested information based on the provided text. The document primarily focuses on regulatory approval and classification, not detailed performance metrics and supporting studies.

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