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510(k) Data Aggregation

    K Number
    K242386
    Device Name
    Bluemoon
    Manufacturer
    GENOSS Co., Ltd.
    Date Cleared
    2025-05-05

    (266 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Product Code :

    EBZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bluemoon is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photopolymerized in the 385~515nm waveband of visible light.
    Device Description
    The Bluemoon Dental Curing Light is an instrument for photopolymerizing dental materials and starting agents by irradiating them with visible light between 385-515nm wavelength. It offers four modes (HYPER, TURBO, LOW, and SOFT START) depending on the output intensity and irradiation time.
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    K Number
    K243921
    Device Name
    LED Curing Lights (DB686 HALO)
    Manufacturer
    Foshan COXO Medical Instrument Co., Ltd.
    Date Cleared
    2025-04-11

    (112 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Product Code :

    EBZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For dental clinics treatment to irradiate polymer-based restorative materials to cure them. The instrument must only be used in hospital environments, clinics or dental offices, by qualified practitioners.
    Device Description
    The LED Curing Lights (Model: DB686 HALO) is an oral device for repairing teeth. It uses the principle of light curing to make the dental repair resin material solidify rapidly under the action of light wave in the specific wavelength range (385~515nm), so as to fill the tooth cavity or bond the bracket. It is a cordless pen-style device, and consists of handpiece, LED cure tip, charging base, power adapter, eyes protector, eye protector unit and disposable protective sleeve. The LED Curing Lights protects the handpiece and LED cure tip from gross contamination and prevent cross infection between patients by applying the disposable protective sleeve. The disposable protective sleeve (patient contact part) is made of PP material.
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    K Number
    K250009
    Device Name
    LED Curing Light (C01-X, C02-X)
    Manufacturer
    Premium Plus (Dongguan) Limited
    Date Cleared
    2025-04-10

    (98 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Product Code :

    EBZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LED Curing Light is intended for use by trained dental professionals only for the purpose of light curing dental resins and composites.
    Device Description
    LED Curing Light is classified as an Ultraviolet Activator for Polymerization (21 CFR 872.6070). It is used for polymerization of dental light cured materials by dental professionals. The device is based on blue LED (light emitting diode) technology. It has four curing modes. Using different modes gives dental professionals the flexibility to polymerize virtually dental resins and composites.
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    K Number
    K241238
    Device Name
    LOOP™ LED Curing Light System (CLK01)
    Manufacturer
    Garrison Dental Solutions, LLC
    Date Cleared
    2024-08-01

    (90 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Product Code :

    EBZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LOOP™ is a source of illumination for curing photo-activated dental restorative materials and adhesives.
    Device Description
    LOOP™ is a high-performance LED (Light Emitting Diode) light source for polymerization of dental materials used by trained dental professionals. It is suitable for use with a broad range of light-cured dental materials including materials for restoratives such as light-cured and dual-cure cements, composites, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations such as ceramic inlays. LOOP™ consists of a wireless handpiece and a charging base with an integrated calibration station. The device is a medical electrical device in accordance with IEC 60601-1-2. LOOP™ features a patented coaxial feedback sensing system that measures the actual irradiance, which is the light power striking the targeted tooth. The feedback data allows LOOPTM to make corrective adjustments to the LED power output hundreds of times per second. This continual corrected "closed loop" operation ensures that the targeted surface of the restorative dental material receives the intended irradiance independent of operator-induced distance variations.
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    K Number
    K223414
    Device Name
    Curing Light, Model: MaxCure 9
    Manufacturer
    Guilin Refine Medical Instrument Co., Ltd.
    Date Cleared
    2023-11-15

    (370 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Product Code :

    EBZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MaxCure9 is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 385~515nm waveband of visible light.
    Device Description
    This Curing Light is a device which generates high intensity light for polymerization of light curing materials used for dental curing purpose. This curing light is intended for use by trained dental professionals for the purpose of light curing dental resins and composites and used to restore teeth.
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    K Number
    K233518
    Device Name
    BASE290 LED Curing Light
    Manufacturer
    Handpiece Headquarters
    Date Cleared
    2023-11-02

    (1 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Product Code :

    EBZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This "BASE290 LED Curing Light" is a dental curing unit utilizing visible light programmed for the polymerization of light curing materials in the wavelength range of 380-500 nm by dental professionals.
    Device Description
    Not Found
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    K Number
    K223507
    Device Name
    CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)
    Manufacturer
    Good Doctors Co., Ltd.
    Date Cleared
    2023-08-04

    (255 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Product Code :

    EBZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CL-DP40 (Dr's Light PRIME)/CL-DP40 (Dr's Light CHOICE)is a hand held LED polymerization light intended to cure dental composites using visible light.
    Device Description
    This unit is a battery type wireless LED curing light. User can adjust light intensity and time by selecting six program modes. Both of Dr's Light PRIME and Dr's Light Choice are characterized by high power intensity, slim head height, large irradiation area (12mm), adjustable intensity power, highly readable color touch screen, 360° twistable head and big capacity of the battery.
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    K Number
    K223142
    Device Name
    Coltolux Comfort LED Curing Light
    Manufacturer
    Dent4You AG
    Date Cleared
    2022-12-22

    (79 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Product Code :

    EBZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coltolux Comfort LED Curing Light is indicated for the polymerization of intra- and extraoral dental restorations fabricated from materials (commonly referred to as visible light cured dental restoratives and/or composites and/or dental adhesives) that contain Camphorquinone as the photoinitiator.
    Device Description
    The proposed Coltolux Comfort LED Curing Light (Coltolux Comfort) is used for the polymerization of light-cured resin materials used in dental restorations. The Coltolux Comfort incorporates a focused high-power LED to produce light in the "deep blue" spectrum (wavelength 440 - 470 nm) for activating Camphorquinone (CQ) photo-initiators. The device is utilized by placement of the lens within close proximity to the surface of the material to be cured, activation of the curing light via the pushbutton switch, and retention of the tip near the dental material until the composite is cured.
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    K Number
    K220826
    Device Name
    LED Curing Light
    Manufacturer
    Foshan COXO Medical Instrument Co., Ltd.
    Date Cleared
    2022-12-08

    (261 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Product Code :

    EBZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For light curing polymerization of dental composites, luting materials, cements and other light cured materials.
    Device Description
    The LED Curing Light is used for light curing polymerization of dental composites, luting materials, cements and other light cured materials. The device is a cordless pen style, LED light polymerization device for use by dental professionals in dental offices or dental laboratories. The LED Curing Light protect the handpiece from gross contamination and prevent cross infection between patients by applying the single use protective sleeve. The protective sleeve (patient contact part) is made of PP material. DB686 NANO: The LED Curing Light DB686 NANO adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of handpiece, cure tip, battery pack, charging base, adapter and protective sleeve. The handpiece contains the Rotary switch, Indicator light and Start key. The LED Curing Light DB686 NANO has one mode namely: Curing light mode. DB686 SWIFT: The LED Curing Light DB686 SWIFT adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of handpiece, cure tip, battery, charging base, adapter and protective sleeve. The handpiece contains the Power/Start button, Mode/ Timer button and LED Display. The LED Curing Light DB686 SWIFT integrates three modes namely: soft up mode, high power mode and orthodontic mode.
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    K Number
    K221152
    Device Name
    CuringPen Dental Curing Light
    Manufacturer
    Changzhou Sifary Medical Technology Co., Ltd.
    Date Cleared
    2022-11-23

    (217 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Product Code :

    EBZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CuringPen Dental 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 380~515nm waveband of visible light. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment.
    Device Description
    The CuringPen Dental Curing Light is designed to polymerize all photo-activated dental materials in the wavelength range of 380-515 nm per ISO 10650:2018. It is a cordless pen-style, LED light polymerization device, and must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment.
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