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

    FotoDent denture

    K Number: K200580 · Decision Nov 19, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    6
    Review Days
    259

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    Basic Information

    Device Name
    FotoDent denture
    K Number
    K200580
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dreve Dentamid GmbH
    Date Received
    March 5, 2020
    Decision Date
    November 19, 2020
    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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