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510(k) Data Aggregation

    K Number
    K083876
    Device Name
    SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT
    Manufacturer
    CENDRES & METAUX SA
    Date Cleared
    2010-02-26

    (424 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K070007
    Why did this record match?
    Reference Devices :

    K070007

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

    The SFI-Bar® is intended to be used with the SPI Element Platform 4.0 mm implant (K070007) to provide support for fixation of overdentures.

    The SFI Bar consists of the following variants:

    SFI-Bar® 2 Implant: Lower jaw: Connecting 2 or 2x2 implants in the intraforaminal region Upper jaw: Connecting 2x2 implants in the anterior/premolar region

    SFI-Bar® 4 Implant: Lower jaw: Connecting 4 implants in the intraforaminal region Upper jaw: Connecting 4 implants in the anterior/premolar region

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental implant abutment (SFI-Bar®), which primarily focuses on its substantial equivalence to a predicate device. It does not include details about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications for performance evaluation.

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