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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 K063659
Device Name EASY CURING PEN-STYLE LED CURING LIGHT
Applicant
Dent Corp. Research & Development
7-11 S. Broadway
White Plains,  NY  10601
Applicant Contact DAVID ALBELDA
Correspondent
Dent Corp. Research & Development
7-11 S. Broadway
White Plains,  NY  10601
Correspondent Contact DAVID ALBELDA
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received12/08/2006
Decision Date 04/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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