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

    CediTEC

    K Number: K220743 · Decision Jul 5, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    167
    Registration Numbers
    167
    Same Product Code
    322
    Applicant Total
    19
    Review Days
    113

    Basic Information

    Device Name
    CediTEC
    K Number
    K220743
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    VOCO GmbH
    Date Received
    March 14, 2022
    Decision Date
    July 5, 2022
    Product Code
    EBI
    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
    EBI Resin, Denture, Relining, Repairing, Rebasing

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