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510(k) Data Aggregation
K Number
K242386Device Name
Bluemoon
Manufacturer
GENOSS Co., Ltd.
Date Cleared
2025-05-05
(266 days)
Product Code
EBZ
Regulation Number
872.6070Why 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
K243921Device 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
872.6070Why 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
K250009Device 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
872.6070Why 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
K241238Device Name
LOOP LED Curing Light System (CLK01)
Manufacturer
Garrison Dental Solutions, LLC
Date Cleared
2024-08-01
(90 days)
Product Code
EBZ
Regulation Number
872.6070Why 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
K223414Device 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
872.6070Why 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
K233518Device Name
BASE290 LED Curing Light
Manufacturer
Handpiece Headquarters
Date Cleared
2023-11-02
(1 days)
Product Code
EBZ
Regulation Number
872.6070Why 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
K223507Device Name
CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE)
Manufacturer
Good Doctors Co., Ltd.
Date Cleared
2023-08-04
(255 days)
Product Code
EBZ
Regulation Number
872.6070Why 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
K223142Device Name
Coltolux Comfort LED Curing Light
Manufacturer
Dent4You AG
Date Cleared
2022-12-22
(79 days)
Product Code
EBZ
Regulation Number
872.6070Why 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
K220826Device Name
LED Curing Light
Manufacturer
Foshan COXO Medical Instrument Co., Ltd.
Date Cleared
2022-12-08
(261 days)
Product Code
EBZ
Regulation Number
872.6070Why 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
K221152Device Name
CuringPen Dental Curing Light
Manufacturer
Changzhou Sifary Medical Technology Co., Ltd.
Date Cleared
2022-11-23
(217 days)
Product Code
EBZ
Regulation Number
872.6070Why 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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