GR-17 Resin System

Crown And Bridge, Temporary, Resin

Pro3dure Medical GmbH

The following data is part of a premarket notification filed by Pro3dure Medical Gmbh with the FDA for Gr-17 Resin System.

Pre-market Notification Details

Device IDK201827
510k NumberK201827
Device Name:GR-17 Resin System
ClassificationCrown And Bridge, Temporary, Resin
Applicant Pro3dure Medical GmbH Am Burgberg 13 Iserlohn,  DE 58642
ContactMartin Klare
CorrespondentPatricia Kontoudis
Regulatory And Quality Solutions, LLC 2790 Mosside Blvd., Suite 800 Monroeville,  PA  15146
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-02
Decision Date2020-11-05

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