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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
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