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510(k) Data Aggregation

    K Number
    K171254
    Device Name
    LeEject 2 Dental Syringe and Needle System
    Manufacturer
    Advanced Technology and Capital, Inc.
    Date Cleared
    2017-11-16

    (202 days)

    Product Code
    EJI, DZM
    Regulation Number
    872.6770
    Why did this record match?
    Applicant Name (Manufacturer) :

    Advanced Technology and Capital, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LeEject 2 Syringe and Needle System is indicated to be used in conjunction with LeEject Needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.
    Device Description
    The LeEject 2 Syringe and Needle System is a side-loading dental syringe with a plastic guard "Safeguard" to secure the needle. After inserting the LeEject Needle hub into the opening of the plastic Safeguard, rotating the "Safeguard" guard clockwise secures the dental needle. The system gives the user the option of recapping the dental needle prior to disposal or unlocking the "Safeguard" and allowing the needle to fall into the sharps container without recapping. The LeEject 2 Syringe's main body is shaped like a standard syringe, apart from having a tapered end with a plastic "safeguard" attached, but has no threads on the tip to screw on the needle. The LeEject 2 Syringe is mostly made of chrome plated brass with the exception of the harpoon and piston rod, which is made of stainless steel. The LeEject 2 Syringe is sold non-sterile, uses a standard 1.8mL anesthetic cartridge. The LeEject needles are EO sterilized, single use and sold separately. Only the LeEject Needle can be used with the LeEject 2 Syringe.
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