Structur CAD

Crown And Bridge, Temporary, Resin

VOCO GmbH

The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Structur Cad.

Pre-market Notification Details

Device IDK201090
510k NumberK201090
Device Name:Structur CAD
ClassificationCrown And Bridge, Temporary, Resin
Applicant VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven,  DE 27472
ContactM. Th. Plaumann
CorrespondentT. Gerkensmeier
VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven,  DE 27472
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-23
Decision Date2020-09-09

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