Bifix Hybrid Abutment Cement

Cement, Dental

VOCO GmbH

The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Bifix Hybrid Abutment Cement.

Pre-market Notification Details

Device IDK220640
510k NumberK220640
Device Name:Bifix Hybrid Abutment Cement
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 Received2022-03-04
Decision Date2022-08-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E22129951 K220640 000
E22124131 K220640 000
E22124121 K220640 000
E22124111 K220640 000
E22124101 K220640 000

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