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 Number | 872.5470
|
Classification Product Code |
|
Date Received | 09/21/2022 |
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
|
|
|