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

    BIOMERS TRANSLUCENT ORTHODONTIC WIRE

    K Number: K081143 · Decision May 2, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    41
    Applicant Total
    1
    Review Days
    10

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    Basic Information

    Device Name
    BIOMERS TRANSLUCENT ORTHODONTIC WIRE
    K Number
    K081143
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomers Product, LLC
    Date Received
    April 22, 2008
    Decision Date
    May 2, 2008
    Product Code
    DYW
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DYW Bracket, Plastic, Orthodontic

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