BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    STRUCTUR 3

    K Number: K120779 · Decision Jun 1, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    183
    Registration Numbers
    183
    Same Product Code
    186
    Applicant Total
    94
    Review Days
    79

    Basic Information

    Device Name
    STRUCTUR 3
    K Number
    K120779
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    VOCO GMBH
    Date Received
    March 14, 2012
    Decision Date
    June 1, 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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