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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 K243621
Device Name Evoblock, Perléon
Applicant
Evoden Indústria Comércio Importação E Exportação
De Produtos Odontológicos Ltda.
R: Genésio De Bem, 1634 Distrito Industrial
Pirassununga,  BR 13633-428
Applicant Contact Jéssica Augusto
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number872.3770
Classification Product Code
EBG  
Subsequent Product Code
EBI  
Date Received11/22/2024
Decision Date 04/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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