Meron Plus QM

Cement, Dental

Voco GmbH

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

Pre-market Notification Details

Device IDK180386
510k NumberK180386
Device Name:Meron Plus QM
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-12
Decision Date2018-05-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E22117281 K180386 000
E22117271 K180386 000

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