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510(k) Data Aggregation
K Number
K192009Device Name
LED Curing Light
Manufacturer
Date Cleared
2020-01-09
(164 days)
Product Code
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
EZGO Group Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For light curing polymerization of dental composites, luting materials, cements and other light cured materials.
Device Description
LED Curing Light is used to restore teeth on dental patient. The device can only be used by the dentist who is qualified and well trained. This product is used on dental patient in the place of hospital or professional medical site.
LED Curing Light adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of high-power LED, main unit, curing light shield, charger and charge station. The main unit contains the ON/OFF button, display screen, mode button and time button.
LED Curing Light provides TURBO mode and NORMAL mode with different preset exposure time. The high-power LED can produce visible blue light in the 430nm to 490nm waveband of spectrum with a power density of 1000m W/cm² to 1800m W/cm². Using different modes gives dental professionals the flexibility to polymerize virtually almost all types of composites, boding agents and sealants available in the market.
The enclosure of main unit was composed of ABS material and Aluminum, and the light quide base (patient contact part) was made from ABS material.
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