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510(k) Data Aggregation

    K Number
    K983105
    Device Name
    CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01
    Manufacturer
    DENTSPLY MIDWEST
    Date Cleared
    1999-03-08

    (185 days)

    Product Code
    EJI
    Regulation Number
    872.6770
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTSPLY MIDWEST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for the injection of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with, dental procedures.
    Device Description
    The CCS computer controlled syringe is a programmable electronic device that allows the injection of local anesthetics commercially available and packaged in cartridge form. The device consists of a programmable control unit, and a handpiece with switches that actuate the function of the device as programmed. Single use, replacement cartridge holders are available to facilitate universal injection technique.
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