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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?
    Product Code :

    EJI

    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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    K Number
    K142414
    Device Name
    Miltex N-Tralig Intraligamentary Syringe
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Date Cleared
    2014-10-30

    (63 days)

    Product Code
    EJI
    Regulation Number
    872.6770
    Why did this record match?
    Product Code :

    EJI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Integra® Miltex® N-Tralig® Intraligamentary Syringe is indicated to be used in conjunction with anesthetic needles and cartridges for injection of anesthetic into the periodontal ligament.
    Device Description
    The Integra® Miltex® N-Traligamentary Syringe is a cartridge syringe intended to inject anesthetic agents into the intraligamentary space (i.e., periodontal ligament). The device consists of a stainless steel syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the barrel cap, the device is used to administer an injection to the patient. The Integra® Miltex® N-Tralig® Intraligamentary Syringe delivers 0.2cc of anesthetic with each ratchet. The ratchet action of the syringe allows for the slow infiltration of anesthetic during the Periodontal Ligament Injection (PDL injection) to help minimize patient discomfort. The 30° adapter helps provide a better angle with difficult-to-reach injections. The syringe comes with a solid barrel and a window barrel.
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    K Number
    K120659
    Device Name
    HU-FRIEDY DENTAL CARTRIDGE SYRINGE
    Manufacturer
    HU-FRIEDY MFG. CO. LLC
    Date Cleared
    2012-11-06

    (246 days)

    Product Code
    EJI
    Regulation Number
    872.6770
    Why did this record match?
    Product Code :

    EJI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These devices are intended for use by dental professionals only. The devices are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.
    Device Description
    Hu-Friedy dental cartridge syringes are made from chrome-plated brass and stainless steel. Syringes are reusable, sterilizable and packaged non-sterile.
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    K Number
    K113247
    Device Name
    ANESTHESIA INJECTION TOOL SET
    Manufacturer
    KI WORKS CO., LTD.
    Date Cleared
    2012-03-27

    (146 days)

    Product Code
    EJI
    Regulation Number
    872.6770
    Why did this record match?
    Product Code :

    EJI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for the injection of local anesthetics for anesthesia administered prior to, or in conjunction with, dental procedures.
    Device Description
    KI works' Anesthesia Injection Tool Set (KIW-1000) is a device for injecting local anesthetic for anesthesia prior to, or in conjunction with, dental procedures. This device consists of Main body, Hand-piece, Battery pack and Adapter. All operating displays and the majority of the operator controls are located on front panel of the control unit.
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    K Number
    K082249
    Device Name
    MORPHEUS
    Manufacturer
    MEIBACH TECH LTDA
    Date Cleared
    2009-12-31

    (510 days)

    Product Code
    EJI
    Regulation Number
    872.6770
    Why did this record match?
    Product Code :

    EJI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MORPHEUS is an instrument intended solely to be used for anesthetic applications inside the oral region in human beings by dentistry professionals certified by local laws.
    Device Description
    Not Found
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    K Number
    K092943
    Device Name
    ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE
    Manufacturer
    ARNOLD TUBER INDUSTRIES
    Date Cleared
    2009-12-11

    (78 days)

    Product Code
    EJI
    Regulation Number
    872.6770
    Why did this record match?
    Product Code :

    EJI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cartridge Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.
    Device Description
    Dental Aspirating Syringes/Self Aspirating Syringes include standard, petite and medium sizes. All syringes are made of stainless steel and have aluminum handles. Syringes are reusable, sterilizable and packaged non-sterile.
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    K Number
    K083796
    Device Name
    MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT
    Manufacturer
    MILTEX, INC.
    Date Cleared
    2009-03-09

    (77 days)

    Product Code
    EJI
    Regulation Number
    872.6770
    Why did this record match?
    Product Code :

    EJI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Miltex® Dental Aspirating Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.
    Device Description
    Miltex® Dental Aspirating Syringes include Standard Aspirating Syringes, Petite Aspirating Syringes, Self-Aspirating Syringe, Lightweight Self-Aspirating Syringe, Articulating Barrel Syringe and GripRite™ Standard and Petite Aspirating Syringes. All syringes are made of chrome-plated brass and stainless steel; Lightweight Self-Aspirating Syringe has aluminum handle. Syringes are reusable, sterilizable and packaged non-sterile.
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    K Number
    K081694
    Device Name
    DENJECTOR
    Manufacturer
    DXM CO., LTD.
    Date Cleared
    2008-09-12

    (87 days)

    Product Code
    EJI
    Regulation Number
    872.6770
    Why did this record match?
    Product Code :

    EJI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for the use of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with dental procedures.
    Device Description
    Denjector is a gun type electronic dental anesthetic cartridge syringe. This device is used with injectable local anesthetics packaged in cartridge form. The device consists of: Injector gun, battery, battery charger stand, DC adapter for battery charger stand, Cartridge holder and Cartridge pushing/pulling pin. Standard needles may be used with the device.
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    K Number
    K061904
    Device Name
    COMPUDENT STA
    Manufacturer
    MILESTONE SCIENTIFIC, INC.
    Date Cleared
    2006-08-08

    (34 days)

    Product Code
    EJI
    Regulation Number
    872.6770
    Why did this record match?
    Product Code :

    EJI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To inject local anesthetic agents subcutaneously or intramuscularly for dental applications.
    Device Description
    The CompuDent STA™ Syringe is a computer controlled syringe consisting of a stationary motor housing which includes a metal piston whose speed of advance is regulated by a foot switch thus controlling the flow rate of anesthetic being injected. The device utilizes hypodermic needles and standard 1.8mm pre-filled carpules manufactured by various third parties. The anesthetic agent reaches the needle by means of a length of flexible vinyl tubing. The handpiece is made of rigid PVC. The holster containing the anesthetic carpule, the tubing and the handpiece are sold in a sterile condition as a disposable assembly for one-time use. The materials, principal of operation and intended use are the same as other marketed piston and cartridge syringes. The device provides audible and visible status indicators of injection rate, amount of anesthetic remaining in the carpule, and pressure at the tip of the needle. It is substantially equivalent to the company's currently marketed CompuDent™ computer controlled syringe.
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    K Number
    K043322
    Device Name
    MIRAMATIC SAFE SYRINGE SYSTEM
    Manufacturer
    HAGER WORLDWIDE, INC.
    Date Cleared
    2005-07-21

    (231 days)

    Product Code
    EJI
    Regulation Number
    872.6770
    Why did this record match?
    Product Code :

    EJI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for use with pre-filled anesthetic cartridges and press fit dental needles for the manual injection of local dental anesthetics into the oral tissues. The cartridge syringe may aid in the reduction of needle stick injuries.
    Device Description
    The Hagar MIRAMATIC System consists of a cartridge syringe (the MIRAMATIC) and dental needles (MIRAJECT). The MIRAMATIC System is a manual system designed exclusively for use with MIRAJECT needles. The hub of the syringe is designed to receive the needle using a compression fit mechanism rather than a threaded screw-on motion or slip-fit. The needles have a corresponding specially designed cone to allow seating by push fit on to the hub. The syringe hub has locked and unlocked positions.
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