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510(k) Data Aggregation

    K Number
    K121093
    Device Name
    D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000
    Manufacturer
    DXM CO., LTD.
    Date Cleared
    2012-11-27

    (231 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    DXM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The D1 LED Curing Light & accessories is intended to polymerize resinous dental materials, restorative composite materials, orthodontic brackets bonding and sealing materials that are photo-polymerized in the 430~490nm waveband of visible light.
    Device Description
    D1 by DXM Co., Ltd. is classified as an Ultraviolet Activator for polymerization (21 CFR 872.6070) because it is a device intended for the photopolymerization light cured dental materials. The D1-Cordless is a universal photo-polymerization light curing source working in cordless conditions and producing visible blue light in the 430 to 490nm waveband of spectrum with a power density of 3,000mW/cm² (11-8mm light-guide). These power densities are sufficient for the product intended uses, namely, Photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) dental materials, restorative composite materials, and orthodontic brackets and orthodontic bonding and sealing materials. D1 has two operating modes: Plasma Emulation/ Ortho mode: 3000 mW/cm² and High Power mode: 1500 mW/cm2. Exposure timing intervals for Plasma Emulation mode is 1, 2, 3 seconds, Ortho: approximately 3 seconds on, 1 second off for 16 cycles and High Power mode: 5, 10, 20, 40 seconds. The D1 Curing light is cordless and is powered by a rechargeable Lithium-lon battery which is charged by a Battery Charger Stand supplied with a certified AC/DC Adapter.
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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?
    Applicant Name (Manufacturer) :

    DXM CO., LTD.

    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
    K042703
    Device Name
    CYBIRD LED CURING LIGHT
    Manufacturer
    DXM CO., LTD.
    Date Cleared
    2004-10-12

    (12 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    DXM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cybird LED Curing Light is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 430-490 nm waveband of visible light.
    Device Description
    Cybird by DXM Co., LTd is classified as an Ultraviolet Activator for polymerization(21 C.f.r.872.6070) because it is a device intended for the photo-polymerization light cured dental materials. The Cybird is a universal photo-polymerization light curing source working in cordless conditions and producing visible blue light in the 440 to 490nm waveband of spectrum with a power density comprised 1,000W/cm², 11-8mm light-guide).These power densities are sufficient for the product intended uses ,namely, Photopolymerization in the 440-490 nm waveband of visible light cured (VLC) dental materials , Photo – polymerization in the 440-490nm waveband of visible light cured(VLC) restorative composite materials, and Photo-polymerization in the 440-490 nm waveband of visible light cured (VLC) orthodontic brackets and orthodontic bonding and sealing materials. Exposure times can be set for 5,10,15, or 20 seconds.
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    K Number
    K040116
    Device Name
    HAWK INTRAORAL CAMERA AND ACCESSORIES
    Manufacturer
    DXM CO., LTD.
    Date Cleared
    2004-04-20

    (91 days)

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

    DXM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hawk Intraoral Camera and Accessories are indicated for use to provide a view of mouth to assist the dentist in describing dental procedures and to show the patient the mouth before and after dental procedures.
    Device Description
    Hawk Intraoral Camera composed of light (25g), small (185 x10mm) hand piece along with docking station. The hand piece consists of a focusing mechanism to assist the doctor in taking video of the patient's mouth. The hand piece connects to docking station via cable. The docking station attaches directly to monitor, TV, or computer via standard composite connection. It uses high definition imaging (480 lines) to capture images at 78 degrees field of view. Hawk Intraoral Camera includes also footswitch.
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