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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cement, dental
510(k) Number K183465
Device Name Allcem, Allcem Core
Dentscare LTDA
Av. Edgar Nelson Meister, 474
joinville,  BR 89219-501
Applicant Contact roberta uyara
United Regulatory LLC
12343 NW 25th St
coral springs,  FL  33065
Correspondent Contact rodrigo abreu
Regulation Number872.3275
Classification Product Code
Subsequent Product Code
Date Received12/14/2018
Decision Date 11/02/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No