BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S

    K Number: K100248 · Decision Oct 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    142
    Applicant Total
    2
    Review Days
    268

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    Basic Information

    Device Name
    DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S
    K Number
    K100248
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3820
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Drfp , Ltd.
    Date Received
    January 27, 2010
    Decision Date
    October 22, 2010
    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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    Other Clearances by Drfp , Ltd.

    K Number Device Name
    K120048 DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S