BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DENTATUS OSCIOMAT

    K Number: K031793 · Decision Nov 13, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    4
    Review Days
    156

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    Basic Information

    Device Name
    DENTATUS OSCIOMAT
    K Number
    K031793
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dentatus USA , Ltd.
    Date Received
    June 10, 2003
    Decision Date
    November 13, 2003
    Product Code
    DZH
    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
    DZH Saw, Bone, Ac-Powered

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