DD CubeX2

Powder, Porcelain

DENTAL DIREKT GMBH

The following data is part of a premarket notification filed by Dental Direkt Gmbh with the FDA for Dd Cubex2.

Pre-market Notification Details

Device IDK150196
510k NumberK150196
Device Name:DD CubeX2
ClassificationPowder, Porcelain
Applicant DENTAL DIREKT GMBH INDUSTRIEZENTRUM 106-108 Spenge,  DE 32139
ContactUwe Greitens
CorrespondentUwe Greitens
DENTAL DIREKT GMBH INDUSTRIEZENTRUM 106-108 Spenge,  DE 32139
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-29
Decision Date2015-03-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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