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510(k) Data Aggregation

    K Number
    K171150
    Device Name
    AW-100
    Manufacturer
    Date Cleared
    2018-03-08

    (323 days)

    Product Code
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Micron Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended to be used for endodontics (canal preparation and canal cleaning).
    Device Description
    The prosed device is used by dental professionals for removal of dentine debris in root canals in the field of endodontics. A turbine hose from a dental unit that supplies the device with compressed air and water is attached of the device in order to use the device. The compressed air is the energy source of the device to generate mechanical vibration. Water from the dental unit is used for cooling and cleaning the treatment site. The device consists of the handpiece including the connection to a hose and file holder. The proposed device has two model 4H connects to the Midwest 4-hole turbine hose and the model K A connects to the KaVo MULTIflex® quick-disconnect coupling. The associated accessories include: - file holder to attach endodontics files - replacement wrench for the holder The proposed device and accessories are supplied non-sterile and must be sterilized in an autoclave prior to the first use and after every patient by the end-user.
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    K Number
    K161639
    Device Name
    Y-MIC
    Manufacturer
    Date Cleared
    2016-12-22

    (191 days)

    Product Code
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRON CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The proposed device is intended to remove plaque and calculus in the areas of dental scaling, and for use in periodontics, endodontics and prosthetic by dental professionals.
    Device Description
    The prosed device is used by dental professionals for removal of dental plaque and calculus, and for cleaning in periodontics, endodontics and prosthetics. To use the device, a hose from a dental unit that supplies the device with compressed air and water is attached to the back end of the device. The compressed air is the energy source of the device to generate mechanical vibration. Water from the dental unit is used for cooling and cleaning the treatment site. When compressed air enters inside of the vibrator in the device, it generates mechanical vibration at the working tip attached to the front end of the device. The working tip contacts teeth and in certain cases, gum of the patient. The removal of plaque and calculus or cleaning is performed by utilizing the vibration. The device consists of the handpiece, connection to a hose and working tips. The associated accessories include: - tips for removal of plaque and calculus - holder tips to attach endodontics files or tooth cleaning brushes - tooth cleaning brushes - tip replacement wrench The proposed device and accessories are supplied non sterilized in an autoclave prior to the first use by the end-user.
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