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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name material, tooth shade, resin
510(k) Number K190758
Device Name Opus Bulk Fill APS, Opus Bulk Fill Flow APS
Applicant
DentsCare LTDA
Av. Edgar Nelson Meister, 474
Joinville,  BR 89219-501
Applicant Contact Roberta Uyara
Correspondent
United Regulatory LLC
12343 NW 25th St
Coral Springs,  FL  33065
Correspondent Contact Rodrigo Abreu
Regulation Number872.3690
Classification Product Code
EBF  
Date Received03/25/2019
Decision Date 09/04/2019
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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