Device Classification Name |
Resin, Root Canal Filling
|
510(k) Number |
K190537 |
Device Name |
BIO-C Sealer Ion+ |
Applicant |
Angelus Industria de Produtos Odontologicos S/A |
Rua Waldir Landgraf, 101 |
Londrina,
BR
86.031-218
|
|
Applicant Contact |
Paulo Sergio Calixto De Oliveira |
Correspondent |
Angelus Industria de Produtos Odontologicos S/A |
Rua Waldir Landgraf, 101 |
Londrina,
BR
86.031-218
|
|
Correspondent Contact |
Juliana Norder Trostdorf |
Regulation Number | 872.3820
|
Classification Product Code |
|
Date Received | 03/04/2019 |
Decision Date | 12/12/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|