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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 K182065
Device Name EVOLUX CAD/CAM PMMA BLOCKS
Applicant
Blue Dent Dental
Rua: Joaquim Jorge Port 1272
Pirassununga,  BR 13636142
Applicant Contact Adriana Paula T I Gomes
Correspondent
Passarini Regulatory Affairs of America, LLC
Miami Center Bldg. 201 S. Biscayne Blvd.
Suite 1200
Miami,  FL  33131
Correspondent Contact Mauro Malzyner
Regulation Number872.3770
Classification Product Code
EBG  
Date Received08/01/2018
Decision Date 12/13/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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