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510(k) Data Aggregation

    K Number
    K120048
    Device Name
    DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S
    Manufacturer
    Date Cleared
    2012-06-20

    (166 days)

    Product Code
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRFP LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DRFP propoint obturation points are designed for permanent sealing of root canals when used with DRFP smartpaste Dental Sealer or Brasseler USA EndoSequence® BC Sealer following established endodontic procedures by qualified healthcare professionals.
    Device Description
    The propoints are identical to the points cleared for marketing with K100248. They are made of a radiopaque core and an opaque hydrophilic coating of cross-linked hydrophilic polymers that have been used in the contact lens industry for more than 20 years. propoints are offered in the traditional 4% and 6% sizes and for use with variable taper files (such as ProTaper™ and Sendoline S5™). They are biocompatible and fully opaque. The hydrophilic coating expands radially to push the sealer into irregularities and voids present in the root canal system for a tight mechanical seal with the dentine. The coating only expands into available space and does not exert pressure on tooth structures. Dimensional length stability is maintained. The points are packaged in clean room conditions and come individually wrapped to prevent cross-contamination. They can be cut to exact tip size and length. No heating or compression equipment is required. Post insertion can commence immediately after root canal has been filled. The hydrophilic properties of the device allow extraction without softeners in revision procedures. propoints are - coated with DRFP smartpaste prior to insertion into the root canal . (K100248) or - inserted after the root canal has been filled with EndoSequence® BC. .
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    K Number
    K100248
    Device Name
    DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S
    Manufacturer
    Date Cleared
    2010-10-22

    (268 days)

    Product Code
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRFP LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DRFP ProSmart Root Canal Obturation System is designed for permanent sealing of root canals following established endodontic procedures by qualified healthcare professionals. The ProSmart Root Canal Obturation System is intended for Prescription Use.
    Device Description
    The ProSmart Root Canal Obturation System is using hydrophilic polymer technology. This causes the material to expand into irregularities and tubules of the root canal to assure a tight mechanical seal with the dentine. The hydrophilic properties of the system allow extraction without softeners in revision procedures. The system consists of ProPoint Obturation Points and ProRes Paste.
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