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510(k) Data Aggregation

    K Number
    K133170
    Device Name
    QUICK JET M
    Manufacturer
    Date Cleared
    2014-03-28

    (162 days)

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

    MICRON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The product is intended to remove dental plaque, stain, and discoloration from tooth surface etc. by dental professionals during dental treatment.
    Device Description
    Both the predicate and the new proposed devices are operated by connecting to a standard turbine connection of a dental unit, which supplies air and water. The device is activated when the dental unit is activated and compressed air and water are supplied to the device. Air enters into the powder chamber where it is mixed with the prophylaxis powder. The mixture of air and water leaves the powder chamber and exits the distal end of the device through the spraying nozzle where the mixture of air and water is enveloped by water spray and directed onto the tooth surface. The mixture of air, water and powder removes dental plaque, stain and discoloration from tooth surface.
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    K Number
    K032995
    Device Name
    SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)
    Manufacturer
    Date Cleared
    2003-11-20

    (56 days)

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

    MICRON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SSS is intended for the applications below in the area of dental treatment by dental professionals. · Removal of dental calculus, plaque or stain This air scaler is intended to remove dental plaque, calculus and stain from tooth surface or root by dental professionals only.
    Device Description
    As with its predicate device, SSS is an air scaler for use by dental professionals. The basic design of the predicate and modified devices are same: both are made in the shape of handpiece like dental turbines, used on a dental treatment unit and activated by compressed air delivered from the dental unit. The common operation principle to the predicate is used in the modified device: When the compressed air runs into scaler's built-in vibratory cartridge, it generates elliptical movement of the scaling tip mounted. The scaling tip movement removes dental calculus, plaque or stain from teeth.
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    K Number
    K991239
    Device Name
    VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2
    Manufacturer
    Date Cleared
    1999-10-18

    (189 days)

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

    MICRON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VIP 60 is an instrument of calculus and plaque removal which the dentist uses for dental treatment. This VIP 60 is used with scaling tips and a coolant water spray for debriding heavy calculus and plaque deposits from tooth and root surfaces.
    Device Description
    The VIP 60 is an air scaler used with scaling tips and a coolant water spray. It is described as causing much less pain, less oppressive pain and irritation, and much less bleeding compared to ultrasonic scaling. It also provides post operative refreshness from pocket irrigation. For operators, it allows direct connection to a handpiece hose, minimum water spraying for clear visibility, and a delicate tip for reaching subgingival pockets, interdental areas, and molar furcations. The delicate tip also allows the operator to feel calculus adherence and avoid touching hypersensitive areas.
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