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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 K143071
Device Name Nacera Pearl
Applicant
DOCERAM MEDICAL CERAMICS GMBH
HESSLINGSWEG 65-67
DORTMUND, NRW,  DE D-44309
Applicant Contact Stefan Drude
Correspondent
DOCERAM MEDICAL CERAMICS GMBH
HESSLINGSWEG 65-67
DORTMUND, NRW,  DE D-44309
Correspondent Contact Stefan Drude
Regulation Number872.6660
Classification Product Code
EIH  
Date Received10/27/2014
Decision Date 06/26/2015
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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