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510(k) Data Aggregation
K Number
K221194Device Name
LEDEX
Manufacturer
Dentmate Technology Co. Ltd.
Date Cleared
2022-09-16
(144 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
Dentmate Technology Co. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LEDEX WL-120 is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.
Device Description
The LEDEX WL-120 device using highly efficient LEDs with a thermal management system, while maintaining consistent performance even in the most challenging and demanding curing needs. The light has four LED curing chips with a range of 390 nm, thus effectively curing all composites. About the light guide rod, it is made of genuine optical fiber which can optimize light conduction and minimize loss of light from source to tip. It therefore ensures the most possible intensity of light at the light guide tip. Furthermore, we design advanced efficient cooling heat sink which accompanies with over temperature protection. The thermal protection circuits prevent the light from overheating and help to keep the device in a safety mode. Automatic memorizing the last group of operation is another unique feature of this device.
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