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510(k) Data Aggregation

    K Number
    K981954
    Device Name
    VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS
    Manufacturer
    HEALTHLINE IMPLANTS, INC.
    Date Cleared
    1999-01-25

    (235 days)

    Product Code
    NRQ
    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

    The implant(s) is designed for use in the edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed or partial dentures, or a single tooth replacement.

    Device Description

    Various Dental Implants with Various abutments

    AI/ML Overview

    I am sorry, but the document provided does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) substantial equivalence letter for "Various Dental Implants with Various Abutments." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. It does not include details on specific device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

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