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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K260152
Device Name Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)
Applicant
Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.
Rua Doutor Procopio Toledo Malta, 62, Morada Dos Deuses
São Carlos,  BR 13562291
Applicant Contact Marcelo Del Guerra
Correspondent
Passarini Regulatory Affairs of America, LLC
10185 Henbury St.
Orlando,  FL  32832
Correspondent Contact Fabio Rahal
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Codes
EBI   PZY  
Date Received01/20/2026
Decision Date 04/23/2026
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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