BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇴 Colombia

    Portux CAD/CAM Disc

    K Number: K192153 · Decision Nov 7, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    180
    Registration Numbers
    180
    Same Product Code
    188
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    Portux CAD/CAM Disc
    K Number
    K192153
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    New Stetic, SA
    Date Received
    August 9, 2019
    Decision Date
    November 7, 2019
    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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