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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K192682
Device Name Orthocem, Ortho Bite
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 Number872.3750
Classification Product Code
DYH  
Subsequent Product Code
EBF  
Date Received09/26/2019
Decision Date 08/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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