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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 K092496
Device Name COPRAN ZR/ORIGIN YZ
Applicant
WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG
LANGHEIDE 9
ESSEN,  DE 45239
Applicant Contact OLIVER PUCKERT
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Regulation Number872.6660
Classification Product Code
EIH  
Date Received08/14/2009
Decision Date 09/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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