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    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇸 Spain

    G-CAM

    K Number: K220329 · Decision Aug 16, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    2
    Review Days
    193

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    Basic Information

    Device Name
    G-CAM
    K Number
    K220329
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Graphenano Dental S.L.
    Date Received
    February 4, 2022
    Decision Date
    August 16, 2022
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

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