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

    EXTRAORAL HEADGEAR

    K Number: K936151 · Decision Aug 1, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    35
    Applicant Total
    24
    Review Days
    217

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    Basic Information

    Device Name
    EXTRAORAL HEADGEAR
    K Number
    K936151
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5500
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dentauraum, Inc.
    Date Received
    December 27, 1993
    Decision Date
    August 1, 1994
    Product Code
    DZB
    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
    DZB Headgear, Extraoral, Orthodontic

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