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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
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 Number872.3275
Classification Product Code
EMA  
Subsequent Product Code
EBF  
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
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