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510(k) Data Aggregation

    K Number
    K250473
    Device Name
    Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus
    Manufacturer
    DCI International LLC
    Date Cleared
    2025-02-19

    (0 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DCI International LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The dental delivery system is a device intended to support the instruments used by the dental practitioner, delivering those instruments to an accessible position during a dental procedure. This device may control and be the means of delivering compressed air, water, vacuum and low voltage electricity to a variety of instruments commonly used in dental practice.
    Device Description
    Not Found
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    K Number
    K151987
    Device Name
    DCI Edge Dental Chair with Operative Unit
    Manufacturer
    DCI
    Date Cleared
    2016-06-01

    (320 days)

    Product Code
    KLC, EIA
    Regulation Number
    872.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    DCI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DCI Edge Dental Chair with operative unit is a device intended to position the patient in such a manner to provide to the dental practitioner visual and manual access to the oral cavity. This device should provide for the ergonomic necessities of most patients, both adults and children, throughout its range of movement. The device shall also be the means of supporting delivery systems for the purpose of standard dental procedures.
    Device Description
    The DCI Edge Chair with Operative Unit is a dental chair with an operative unit attached. There are three main parts to the proposed device: a dental chair, dental light and dental chair has adjustable headrest, backrest, seat height and armrests. The dental chair unit consists of a floor box to which are attached a number of operative units: lights, cuspidor, cup filling device, control panel, and foot control. The instrument panel also includes a 3-way syringe and salvia ejector.
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    K Number
    K090959
    Device Name
    LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA
    Manufacturer
    D'ANTONIO CONSULTANTS INTERNATIONAL, INC. (DCI)
    Date Cleared
    2009-12-24

    (262 days)

    Product Code
    KZE
    Regulation Number
    880.5430
    Why did this record match?
    Applicant Name (Manufacturer) :

    (DCI)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LectraJet Needle-Free Injection System is intended to deliver subcutaneous (SQ) or intramuscular (IM) injections of vaccines and other injectable medications. The LectraJet Needle-Free Injection System may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The LectraJet Needle-Free Injection System may also be used by patients to self inject or to have other individuals administer injections of prescribed medications.
    Device Description
    The components of the LectraJet® Needle-Free Injection System include the needle-free single-use syringes with disposable vial adapter and cap with plunger rod attached and the injector handpiece with manual reset mechanism. The LectraJet® handpiece and reset mechanism are sold as a complete injection system contained within a carrying case. The carrying case is an accessory of convenience that provides for portability, organization, and ease of use for the practitioner. The LectraJet® syringes are packaged sterile and designed to be filled by the end user at the time of use. The polycarbonate syringes have a molded orifice at the front end. The syringe orifice is available in sizes 0.006", 0.008", 0.010" and 0.012" diameter, which allows the user to choose the syringe appropriate for the desired depth of penetration (IM/SQ) and patient selection (child/adult). The syringes have a flange at the back end that is held by the injector handpiece when delivering the injection. Syringes are designed to be used immediately upon filling, similar to a traditional needle and syringe, and identical to the Biojector 2000® and Medi-Jector Vision® syringe filling philosophy. After the syringes are filled, they are inserted directly into the LectraJet® handpiece. The LectraJet® handpiece contains a spring drive system that, when compressed, provides the energy to deliver the injection. To compress the spring, the handpiece is placed in a manual reset mechanism and hand pressure is applied to the reset mechanism lever. In the Medi-Jector Vision®, the manual power source used to compress the spring is a hand-twist knob. In the Biojector 2000®, the power source is either a gas cartridge or a gas cylinder. When the LectraJet® handpiece is actuated, the spring drive system is released, and the handpiece ram contacts the syringe piston to drive the injectate out through the syringe orifice, creating a jet stream with enough energy to penetrate the tissue. This is identical in principle to the Biojector 2000® and the spring powered Medi-Jector Vision®. After the injection, the used syringe is released into an appropriate trash container. Little maintenance is required for the LectraJet® handpiece. There are no o-rings or seals to change. No sterilization of the handpiece is required. All of the above features are similar to the Biojector 2000® and the Medi-Jector Vision®, predicate devices and accessories.
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