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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat Source For Bleaching Teeth
510(k) Number K063704
FOIA Releasable 510(k) K063704
Device Name BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101
Applicant
Beks Incorporated
694 Bluff St. # 104
Carol Stream,  IL  60188
Applicant Contact JILL CREASY
Correspondent
Beks Incorporated
694 Bluff St. # 104
Carol Stream,  IL  60188
Correspondent Contact JILL CREASY
Regulation Number872.6475
Classification Product Code
EEG  
Date Received12/13/2006
Decision Date 02/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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