Nacera Pearl

Powder, Porcelain

DOCERAM MEDICAL CERAMICS GMBH

The following data is part of a premarket notification filed by Doceram Medical Ceramics Gmbh with the FDA for Nacera Pearl.

Pre-market Notification Details

Device IDK143071
510k NumberK143071
Device Name:Nacera Pearl
ClassificationPowder, Porcelain
Applicant DOCERAM MEDICAL CERAMICS GMBH HESSLINGSWEG 65-67 Dortmund, Nrw,  DE D-44309
ContactStefan Drude
CorrespondentStefan Drude
DOCERAM MEDICAL CERAMICS GMBH HESSLINGSWEG 65-67 Dortmund, Nrw,  DE D-44309
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-27
Decision Date2015-06-26
Summary:summary

NIH GUDID Devices

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