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510(k) Data Aggregation

    K Number
    K061581
    Device Name
    EXCEL HIGH SPEED DENTAL HANDPIECE
    Manufacturer
    ORTHOSOURCE, INC.
    Date Cleared
    2006-08-16

    (70 days)

    Product Code
    EFA
    Regulation Number
    872.4200
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The dental high speed handpiece is a precision instrument used by a dental professional for the removal of carious tissue, the preparation of teeth for restorations, for crowns and bridges, and for cosmetic corrections. Note Federal Law restricts the use of this device to dental professionals.

    Device Description

    Excel High Speed Hand Piece

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a dental handpiece, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, intended use, and general controls, but does not include details on specific performance acceptance criteria or performance study results.

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