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510(k) Data Aggregation

    K Number
    K220346
    Device Name
    Lotus Prophy Angle
    Manufacturer
    AJK Engineering, Inc.
    Date Cleared
    2022-11-07

    (273 days)

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

    AJK Engineering, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Lotus Prophy Angle is for polishing and cleaning teeth.
    Device Description
    Lotus Prophy Angle is a device used for polishing and cleaning the surface of teeth. It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth. Lotus Prophy Angle is intended for single use only and is provided aseptic in sealed packaging to be prevent contamination.
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