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510(k) Data Aggregation

    K Number
    K072754
    Device Name
    AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE
    Date Cleared
    2008-01-25

    (120 days)

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

    AXENIC DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Axenic Dental, Inc. DHP™ "Disposable High-Performance" sterile, pyrogen free, maintenance free handpiece, with appropriate burs, is indicated for all dental practice procedures for which metal handpieces are used, including cutting, shaping and preparing teeth for cavity repair, crowns and bridges. The device is suitable for use in circumstances where infectious, inter-patient contamination is a concern. The device can be used for duration of 12 to 14 minutes cutting time during single patient use.
    Device Description
    The Axenic Dental, Inc. DHP™ "Disposable High-Performance Handpiece" is a sterile, single patient use, disposable instrument that is substantially equivalent to standard, re-usable, metal or plastic handpieces. All Axenic DHP™, high-speed, dental hand pieces are designed to operate at maximum specification outputs for 12 to 14 minutes of use. The single patient use nature of the instrument precludes any necessity for maintenance, cleaning, or sterilization.
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