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

    BIOROOT RCS

    K Number: K130601 · Decision Oct 17, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    142
    Applicant Total
    9
    Review Days
    224

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    Basic Information

    Device Name
    BIOROOT RCS
    K Number
    K130601
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3820
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novocol, Inc.
    Date Received
    March 7, 2013
    Decision Date
    October 17, 2013
    Product Code
    KIF
    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
    KIF Resin, Root Canal Filling

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