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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    TYCOM DENTAL

    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
    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?
    Applicant Name (Manufacturer) :

    TYCOM DENTAL

    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.
    Ask a Question

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