Visalys CemCore, Visalys Cem Core Try In Paste

Cement, Dental

Kettenbach GmbH & Co. KG

The following data is part of a premarket notification filed by Kettenbach Gmbh & Co. Kg with the FDA for Visalys Cemcore, Visalys Cem Core Try In Paste.

Pre-market Notification Details

Device IDK191527
501k NumberK191527
Device Name:Visalys CemCore, Visalys Cem Core Try In Paste
ClassificationCement, Dental
Applicant Kettenbach GmbH & Co. KG Im Heerfeld 7 Eschenburg,  DE 35713
ContactKatja Simon
CorrespondentKatja Simon
Kettenbach GmbH & Co. KG Im Heerfeld 7 Eschenburg,  DE 35713
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-10
Decision Date2019-11-08

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