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

    LeEject 2 Dental Syringe and Needle System

    K Number: K171254 · Decision Nov 16, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    44
    Applicant Total
    1
    Review Days
    202

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    Basic Information

    Device Name
    LeEject 2 Dental Syringe and Needle System
    K Number
    K171254
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Technology and Capital, Inc.
    Date Received
    April 28, 2017
    Decision Date
    November 16, 2017
    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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