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

    FLASH PENTA MB QUICK, FLASH MB QUICK

    K Number: K140602 · Decision Jun 5, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    401
    Applicant Total
    6
    Review Days
    87

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    Basic Information

    Device Name
    FLASH PENTA MB QUICK, FLASH MB QUICK
    K Number
    K140602
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3M Espe AG
    Date Received
    March 10, 2014
    Decision Date
    June 5, 2014
    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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    Other Clearances by 3M Espe AG

    K Number Device Name
    K133400 FLASH BITE
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    K110508 SUGLUE-10
    K110302 ADHESIVE EXL-759
    K111257 HEISENBERG DYEING LIQUIDS