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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 K231859
Device Name PrimmaArt
Applicant
Dentscare Ltda
Av. Edgar Nelson Meister, 474
Joinville,  BR 89219-501
Applicant Contact Roberta Uyara
Correspondent
United Regulatory, LLC
2950 W. Cypress Creek Rd. Suite 110
Fort Lauderdale,  FL  33309
Correspondent Contact Rodrigo Abreu
Regulation Number872.3770
Classification Product Code
EBG  
Subsequent Product Code
POW  
Date Received06/23/2023
Decision Date 11/26/2024
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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