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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
New Stetic S.A.
Carrera 53 No. 50 - 09
guarne - antioquia,  CO
Applicant Contact juan david jaramillo g.
Aclivi Consulting
6455 Farley Road
pinckney,  MI  48169
Correspondent Contact chris brown
Regulation Number872.3770
Classification Product Code
Subsequent Product Codes
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