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510(k) Data Aggregation

    K Number
    K061897
    Device Name
    EXCEL CONTRA ANGLE HANDPIECE
    Manufacturer
    ORTHOSOURCE, INC.
    Date Cleared
    2007-02-14

    (226 days)

    Product Code
    EGS
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOSOURCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The dental slow speed handpiece is a precision instrument used by a dental professional at slow speed (100 to 20,000 rpm) for the removal of carious tissue, the preparation of teeth for restorations, for crowns and bridges, for cosmetic correction, and for the trimming, finishing, and polishing of all types of dental restorations and prostheses. Note: Federal Law restricts the use of this device to dental professionals.
    Device Description
    Excel Contra Angle Hand Piece
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOSOURCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
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