Portux CAD/CAM Disc

Crown And Bridge, Temporary, Resin

New Stetic S.A.

The following data is part of a premarket notification filed by New Stetic S.a. with the FDA for Portux Cad/cam Disc.

Pre-market Notification Details

Device IDK192153
501k NumberK192153
Device Name:Portux CAD/CAM Disc
ClassificationCrown And Bridge, Temporary, Resin
Applicant New Stetic S.A. Carrera 53 No. 50 - 09 Guarne - Antioquia,  CO
ContactJuan David Jaramillo G.
CorrespondentChris Brown
Aclivi Consulting 6455 Farley Road Pinckney,  MI  48169
Product CodeEBG  
Subsequent Product CodeEBI
Subsequent Product CodeMQC
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-09
Decision Date2019-11-07

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