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510(k) Data Aggregation

    K Number
    K041458
    Device Name
    MARE DENTAL OPERATIVE UNIT
    Date Cleared
    2004-08-24

    (84 days)

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

    DENIMED ELECTRONICA S.H.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Mare Dental Operative Unit and Accessories is intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental office.
    Device Description
    The Mare Dental Operative Unit provides connections for five pneumatically operated instruments. The unit can supply air, water and electricity, which may include an air water syringe, high and low speed handpiece, electric motors, ultrasonic scalers, and dental curing lights, these accessories are not part of the unit. The unit provides automatic instrument selection by means of a five way pneumatic valve located in each instrument hanger assembly. The automatic selection takes place when a static air pressure signal is removed from the top of a diaphragm located in the handpiece control block. The Mare Dental Operative Unit consists of the following components: - l. Patient Treatment Chair: It has two controls; a foot control and a digital pad in the instruments console for all chair positions, auto return system, preset position, emergency stop system and electric cup filler. The entire Mare features an articulating, detachable headrest. - II. Cuspidor with Water Unit: The ceramic bowl, cup fillers and the bowl irrigator are detachable. The Mare features a swivel ceramic bowl. - III. Dental Light: The Unit features a lamp with two intensity settings. - IV. Instruments Console: Features an instruments auto selection system and a master digital control. - V. Rolling Chair: Height adjustable backrest and inclination setting.
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