Provicol QM Aesthetic

Cement, Dental

VOCO GmbH

The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Provicol Qm Aesthetic.

Pre-market Notification Details

Device IDK201856
510k NumberK201856
Device Name:Provicol QM Aesthetic
ClassificationCement, Dental
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 CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-06
Decision Date2020-08-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E22111081 K201856 000
E22111081 K201856 000
E22111081 K201856 000
E22111081 K201856 000
E22111081 K201856 000
E22111081 K201856 000
E22111081 K201856 000
E22111081 K201856 000
E22111081 K201856 000
E22111081 K201856 000
E22111081 K201856 000

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