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510(k) Data Aggregation

    K Number
    K964860
    Device Name
    MARK 20 AND MARK 25 HAND ENGINE CONTROLLER
    Manufacturer
    BELL INTL., INC.
    Date Cleared
    1997-03-03

    (89 days)

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

    BELL INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Engine, power supply and controller for dental handpiece
    Device Description
    The new device submission covers two handengine controllers designed to operate the 45E and RX-100 dental handengines. The 45E and the RX-100 are low-voltage DC-motors with Econnector type front ends. Both the RX-100 may be operated by the Mark 20 or Mark 25 Controller. Both engines have Off/On or variable speed footswitches. Both engines accept various and straight front handpieces on the motor to do different types of dental work or surgical procedures. The Mark 20 and Mark 25 Controllers are typical rheostat based hand engine controllers. The Mark 20 or Mark 25 Controller allows the practitioner infinite control over the speed of the engine and dental front handpiece up to the rated speed capacity of the selected engine and handpiece. Both the Mark 20 and Mark 25 Controller allow the selected hand engine and dental front hand piece to be operated in forward or reverse directions as well as by local control or remote foot switch. Dental or endodontic surgical procedures needing irrigation are supported by the integral fluid pump. The pump is constant speed in the Mark 20 and is variable speed in the Mark 25 unit.
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    K Number
    K964863
    Device Name
    MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN
    Manufacturer
    BELL INTL., INC.
    Date Cleared
    1997-02-28

    (86 days)

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

    BELL INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Engine, power supply and controller for dental handpiece
    Device Description
    This submission covers the BELL INTERNATIONAL, INC. series of electric dental hand-engines. BELL INTERNATIONAL. INC. offers a complete line of electric motor drive hand-engines for dental restoration and surgical applications. The handengines accept various available "E-type connector" angled and straight front-handpieces produced by many different manufacturers. The different E-type front-handpieces are designed to do different types of dental work or surgical procedures. This includes those front-handpieces that multiply or reduce terminal shaft speed.
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