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

    StoneBite and StoneBite scan

    K Number: K190571 · Decision Nov 7, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    401
    Applicant Total
    6
    Review Days
    246

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    Basic Information

    Device Name
    StoneBite and StoneBite scan
    K Number
    K190571
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dreve Dentamid GmbH
    Date Received
    March 6, 2019
    Decision Date
    November 7, 2019
    Product Code
    ELW
    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
    ELW Material, Impression

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