BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇪 Germany

    CERADRILL

    K Number: K071352 · Decision Jun 29, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    264
    Registration Numbers
    264
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    45

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    Basic Information

    Device Name
    CERADRILL
    K Number
    K071352
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3240
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gebr. Brasseler GmbH & Co. KG
    Date Received
    May 15, 2007
    Decision Date
    June 29, 2007
    Product Code
    EJL
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EJL Bur, Dental

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