Admira Fusion 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 Admira Fusion X-tra.

Pre-market Notification Details

Device IDK151956
510k NumberK151956
Device Name:Admira Fusion 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 Received2015-07-15
Decision Date2015-10-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E22128151 K151956 000
E22128141 K151956 000
E22128111 K151956 000
E22128101 K151956 000
E22128081 K151956 000

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