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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name activator, ultraviolet, for polymerization
510(k) Number K121093
Device Name D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000
Original Applicant
DXM CO., LTD.
55 northern blvd.
great neck,  NY  11021
Original Contact jigar shah
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received04/10/2012
Decision Date 11/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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