BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SMART BURS TOTAL CARBIDES

    K Number: K920243 · Decision Mar 25, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    264
    Registration Numbers
    264
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    68

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    Basic Information

    Device Name
    SMART BURS TOTAL CARBIDES
    K Number
    K920243
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3240
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vermont Diamond Instruments
    Date Received
    January 17, 1992
    Decision Date
    March 25, 1992
    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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