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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
Applicant
Dxm Co., Ltd.
55 Northern Blvd.
Great Neck,  NY  11021
Applicant Contact JIGAR SHAH
Correspondent
Dxm Co., Ltd.
55 Northern Blvd.
Great Neck,  NY  11021
Correspondent Contact JIGAR SHAH
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received04/10/2012
Decision Date 11/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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