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

    PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013

    K Number: K071182 · Decision Jul 11, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    38
    Applicant Total
    92
    Review Days
    72

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    Basic Information

    Device Name
    PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013
    K Number
    K071182
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3920
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nobel Biocare AB
    Date Received
    April 30, 2007
    Decision Date
    July 11, 2007
    Product Code
    ELL
    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
    ELL Teeth, Porcelain

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