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

    PROROOT MTA WHITE, PROROOT MTA GRAY

    K Number: K142178 · Decision Feb 26, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    137
    Applicant Total
    5
    Review Days
    202

    Basic Information

    Device Name
    PROROOT MTA WHITE, PROROOT MTA GRAY
    K Number
    K142178
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3820
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DENTSPLY INTERNATIONAL INC.
    Date Received
    August 8, 2014
    Decision Date
    February 26, 2015
    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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