BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CYBERJET LOCAL ANESTHESIA SYSTEM

    K Number: K964802 · Decision May 27, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    179

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    Basic Information

    Device Name
    CYBERJET LOCAL ANESTHESIA SYSTEM
    K Number
    K964802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4475
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intra Vantage, Inc.
    Date Received
    November 29, 1996
    Decision Date
    May 27, 1997
    Product Code
    EGM
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EGM Injector, Jet, Mechanical-Powered

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