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    K Number
    K062856
    Device Name
    TF ROTARY NICKEL TITANIUM FILE
    Manufacturer
    ORMCO CORP.
    Date Cleared
    2006-12-13

    (79 days)

    Product Code
    EKS
    Regulation Number
    872.4565
    Why did this record match?
    Product Code :

    EKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TF Rotary Nickel Titanium File is a rotary endodontic file designed for use in root canal preparation.
    Device Description
    The TF Rotary Nickel Titanium File is an engine (rotary) driven endodontic file intended for use in root canal preparation. The TF Rotary Nickel Titanium File is made from a single bar stock of nickel titanium that is machined and formed to create a single-piece file (handle, shaft and working portion). Flutes are ground throughout the working portion, forming the cutting edges of the instrument and creating a tapered triangular cross-section. The file blank is heat annealed and the working portion is twisted to form helical cutting edges. The file is twisted instead of ground which enhances its flexibility and durability. The TF Rotary Nickel Titanium File has a non-cuttting (passive) tip and variable helical flute angle. The single-piece unit is intended to prevent separation of the handle from the shaft/working portion.
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    K Number
    K004031
    Device Name
    NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES
    Manufacturer
    DENTAL POWER, INC.
    Date Cleared
    2001-03-28

    (90 days)

    Product Code
    EKS
    Regulation Number
    872.4565
    Why did this record match?
    Product Code :

    EKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K971319
    Device Name
    NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES
    Manufacturer
    TYCOM DENTAL
    Date Cleared
    1997-05-22

    (42 days)

    Product Code
    EKS
    Regulation Number
    872.4565
    Why did this record match?
    Product Code :

    EKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NT and Mac Series Endodontic Files are engine files and hand instruments designed for use in root canal preparation.
    Device Description
    The NT and Mac Series Endodontic Files are a series of engine (rotary) driven and hand driven endodontic files for use in root canal preparation. The files are constructed of nickel-titanium and color coded for ease of use. The files are available in 21 and 25mm lengths and ten graduating sizes.
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    K Number
    K970649
    Device Name
    HERO 642
    Manufacturer
    MICRO-MEGA
    Date Cleared
    1997-05-16

    (85 days)

    Product Code
    EKS
    Regulation Number
    872.4565
    Why did this record match?
    Product Code :

    EKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962031
    Device Name
    QUANTEC SERIES 2000 ENDODONTIC FILES
    Manufacturer
    TYCOM DENTAL
    Date Cleared
    1996-06-04

    (11 days)

    Product Code
    EKS
    Regulation Number
    872.4565
    Why did this record match?
    Product Code :

    EKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantec Series 2000 Endodontic Files are designed for use in root canal preparation.
    Device Description
    The Quantec Series 2000 Endodontic Files are a series hand driven and engine (rotary) driven endodontic files for use in root canal preparation. The files are constructed of nickel-titanium and color coded for ease of use. The files are available in 17, 21 and 25mm lengths and ten graduating sizes.
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