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510(k) Data Aggregation

    K Number
    K150490
    Device Name
    UnicLine Mobile
    Manufacturer
    Date Cleared
    2015-04-17

    (51 days)

    Product Code
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Heka Dental A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UNICLINE MOBILE is an electrically powered, self-contained mobile dental operative unit intended to supply power to and serve as a base for other dental devices and instruments. The system is indicated for performing general dental procedures. The device is intended for operation and use in a clinical setting by legally qualified professionals.
    Device Description
    The new UNICLINE MOBILE is an electrically powered, self-contained mobile dental operative unit consisting of a mobile cart, foot control, internal water supply containers, suction, and mobile patient chair. It contains a foot control that allows the dental professional to engage the features using only the foot. Instrument status is viewable in a single place using a multi-display feature. The instrument arms are spring balanced for ease of use and the extra long connection hoses have been designed for use in any position. The new UNICLINE MOBILE is designed to ensure patient comfort and safety in any of the chair positions. The handles, instrument support, and upholstery are easy to disassemble and clean. The unit uses compressed air and water, and includes a suction element. The cart contains the motors that operate the instrument connections. There are two movable arms that protrude from the top of the cart. One arm contains the optional OEM dental operating lamp that the dentist can position to light the area being worked on. The other arm supports an instrument table. The table contains five spring-loaded smaller arms, an instrument tray, and the instrument display. The new UNICLINE MOBILE spring-loaded arms connect with OEM dental instruments and provide power to them. Once connected, the display indicates whether the air and water spray are on, the time, and the speed of the active motor. The display also includes a timer for use with a light polymerization instrument. The dental professional uses the foot control to operate all functions and instruments of this dental operative unit. The unit was designed for mobility and ease of positioning. The cart is made of fire retardant medium density fiberboard (MDF) coated with paint and its two arms are made of anodized, lacquered aluminum. All selected materials are biocompatible. The chair is made with casted aluminum and imitation leather upholstery. Both the cart and chair contain wheels on one side to allow each piece to be positioned for optimal use of available floor space before connecting via the stabilizing plate.
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