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510(k) Data Aggregation

    K Number
    K020833
    Device Name
    BOYD DELIVERY UNIT
    Manufacturer
    BOYD INDUSTRIES, INC.
    Date Cleared
    2002-08-08

    (147 days)

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

    BOYD INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Boyd delivery systems are intended for use by Dental Professionals for effective treatment of patients.
    Device Description
    The Boyd Delivery Unit is a Dental Operative Unit that provides the dentist with primary requirements for a dental operatory. The delivery system is designed to be used as an interface device to connect the dental operatory hand instruments to the appropriate supply utility such as air, water suction, drain and electricity. It functions as a system management device that provides a method of operating various hand instruments from a single control input device. The unit is furnished with controls that allow the dentist or operator to set the air pressure and water flow to the hand pieces and the syringe in the delivery head. The unit is of a stackable design providing a base for dental tools and accessories. Assistant's instrumentation delivery system, water heater, and the cuspidor are all features that this unit can offer.
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    K Number
    K971941
    Device Name
    AQUA SPRAY
    Manufacturer
    BOYD INDUSTRIES, INC.
    Date Cleared
    1997-08-14

    (79 days)

    Product Code
    GEY
    Regulation Number
    878.4820
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOYD INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aqua Spray is intended for use by Podiatric professionals as an accessory to a burr. The Aqua Spray provides an electric hand piece with an attachment that provides a fine mist of isopropyl alcohol and distilled water (50% concentration) to be dispensed over the burr. The purpose of this mist is to cool the burr and treatment area. In addition, the mist wets the treatment area, thus minimizing the amount of nail dust that becomes airborne during the nail debridement procedure.
    Device Description
    The Aqua Spray is an electrically powered accessory to a burr. The Aqua Spray enables a burr to be attached to an electric hand piece capable of 30,000 rpm, in each direction. A small reservoir in which a 50% distilled water and isopropyl alcohol is placed is included in the unit. A small air pump sprays the water/alcohol liquid in a fine mist on the burr. The mist cools the area and prevents nail dust from the treatment area to become airborne.
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