BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    STABIDENT LOCAL ANESTHESIA SYSTEM

    K Number: K910446 · Decision Jun 3, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    140

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    Basic Information

    Device Name
    STABIDENT LOCAL ANESTHESIA SYSTEM
    K Number
    K910446
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4730
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Fairfax Dental, Inc.
    Date Received
    January 14, 1991
    Decision Date
    June 3, 1991
    Product Code
    DZM
    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
    DZM Needle, Dental

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