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

    Miltex N-Tralig Intraligamentary Syringe

    K Number: K142414 · Decision Oct 30, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    44
    Applicant Total
    65
    Review Days
    63

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    Basic Information

    Device Name
    Miltex N-Tralig Intraligamentary Syringe
    K Number
    K142414
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.6770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integra LifeSciences Corporation
    Date Received
    August 28, 2014
    Decision Date
    October 30, 2014
    Product Code
    EJI
    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
    EJI Syringe, Cartridge

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