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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K123680
Device Name COPRANCOLOR
Applicant
White Peaks Dental Systems GmbH & Co. KG
Langheide 9
Essen,  DE 45239
Applicant Contact OLIVER PUCKERT
Correspondent
White Peaks Dental Systems GmbH & Co. KG
Langheide 9
Essen,  DE 45239
Correspondent Contact OLIVER PUCKERT
Regulation Number872.6660
Classification Product Code
EIH  
Date Received11/30/2012
Decision Date 02/21/2013
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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