BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇹 Italy

    MONOSTERYL

    K Number: K926205 · Decision Feb 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    264
    Registration Numbers
    264
    Same Product Code
    26
    Applicant Total
    1
    Review Days
    428

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    Basic Information

    Device Name
    MONOSTERYL
    K Number
    K926205
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3240
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Utensili Super Abrasivi
    Date Received
    December 9, 1992
    Decision Date
    February 10, 1994
    Product Code
    EJL
    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
    EJL Bur, Dental

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