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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bracket, Ceramic, Orthodontic
510(k) Number K222847
Device Name Ceramic Brackets Orthometric
Applicant
Orthometric - Industria e Comercio de Produtos Medicos
E Odontologicos
Irineu Martins, 280, Distrito de Lacio
Marilia,  BR 17539-059
Applicant Contact Silvio Zilio
Correspondent
PR Servicos Regulatorios Administrativos Ltda
Rua Alice Aem Saadi, 855/ 2402
Ribeirao Preto,  BR 14096570
Correspondent Contact Tatiana Jabor Botura
Regulation Number872.5470
Classification Product Code
NJM  
Date Received09/21/2022
Decision Date 05/04/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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