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

    POWER COINS GLOW IN THE DARK LIGATURES

    K Number: K980864 · Decision Apr 20, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    24
    Applicant Total
    7
    Review Days
    46

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    Basic Information

    Device Name
    POWER COINS GLOW IN THE DARK LIGATURES
    K Number
    K980864
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ortho Kinetics Corp.
    Date Received
    March 5, 1998
    Decision Date
    April 20, 1998
    Product Code
    ECI
    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
    ECI Band, Elastic, Orthodontic

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