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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name crown and bridge, temporary, resin
510(k) Number K192153
Device Name Portux CAD/CAM Disc
Applicant
New Stetic S.A.
Carrera 53 No. 50 - 09
guarne - antioquia,  CO
Applicant Contact juan david jaramillo g.
Correspondent
Aclivi Consulting
6455 Farley Road
pinckney,  MI  48169
Correspondent Contact chris brown
Regulation Number872.3770
Classification Product Code
EBG  
Subsequent Product Codes
EBI   MQC  
Date Received08/09/2019
Decision Date 11/07/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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