GrandioSO X-tra

Material, Tooth Shade, Resin

VOCO GmbH

The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Grandioso X-tra.

Pre-market Notification Details

Device IDK181312
510k NumberK181312
Device Name:GrandioSO X-tra
ClassificationMaterial, Tooth Shade, 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 CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-17
Decision Date2018-08-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E22127141 K181312 000
E22125991 K181312 000
E22125981 K181312 000
E22125971 K181312 000
E22125961 K181312 000
E22125951 K181312 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.