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

    STAINLESS STEEL ORTHODONTIC PRODUCTS

    K Number: K931980 · Decision Sep 1, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    2
    Applicant Total
    8
    Review Days
    132

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    Basic Information

    Device Name
    STAINLESS STEEL ORTHODONTIC PRODUCTS
    K Number
    K931980
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ortho Organizers, Inc.
    Date Received
    April 22, 1993
    Decision Date
    September 1, 1993
    Product Code
    DYO
    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
    DYO Band, Material, Orthodontic

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