V-Print Splint

Mouthguard, Prescription

VOCO GmbH

The following data is part of a premarket notification filed by Voco Gmbh with the FDA for V-print Splint.

Pre-market Notification Details

Device IDK201091
510k NumberK201091
Device Name:V-Print Splint
ClassificationMouthguard, Prescription
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 CodeMQC  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-23
Decision Date2020-11-06

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