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    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇮 Slovenia

    PMMA CAD/CAM DISC

    K Number: K112967 · Decision Aug 28, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    180
    Registration Numbers
    180
    Same Product Code
    188
    Applicant Total
    2
    Review Days
    328

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    Basic Information

    Device Name
    PMMA CAD/CAM DISC
    K Number
    K112967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Polident D.O.O., Dental Products Industry
    Date Received
    October 5, 2011
    Decision Date
    August 28, 2012
    Product Code
    EBG
    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
    EBG Crown And Bridge, Temporary, Resin

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    Other Clearances by Polident D.O.O., Dental Products Industry

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