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

    AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM

    K Number: K982088 · Decision Sep 4, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    35
    Applicant Total
    7
    Review Days
    81

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    Basic Information

    Device Name
    AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM
    K Number
    K982088
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5500
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ortho Kinetics Corp.
    Date Received
    June 15, 1998
    Decision Date
    September 4, 1998
    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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