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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Synthetic, Intraoral
510(k) Number K221851
Device Name Lumina-PTFE Titanium
Applicant
Criteria Industria E Comercio DE Produtos Medicinais
E Odontologicos Ltda
Alameda Sinlioku Tanaka, 170, Galpao 44- Parque Technologico
Sao Carlos,  BR 13.565-261
Applicant Contact Andre Hamar Braga
Correspondent
Pr Servicos Regulatorios Administrativos Ltda
Rua Alice Alem Saadi, 855, 2402
Ribeirao Preto,  BR 14096570
Correspondent Contact Graziela Brum
Regulation Number872.3930
Classification Product Code
NPK  
Date Received06/27/2022
Decision Date 12/08/2023
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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