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

    NITINOL GENTLE TOUCH COIL SPRING

    K Number: K923839 · Decision Oct 15, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    168
    Same Product Code
    29
    Applicant Total
    6
    Review Days
    77

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    Basic Information

    Device Name
    NITINOL GENTLE TOUCH COIL SPRING
    K Number
    K923839
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ultimate Wireforms, Inc.
    Date Received
    July 30, 1992
    Decision Date
    October 15, 1992
    Product Code
    DZC
    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
    DZC Wire, Orthodontic

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