Device Classification Name |
resin, root canal filling
|
510(k) Number |
K180185 |
Device Name |
BIO-C REPAIR |
Applicant |
Angelus Industria de Produtos Odontologicos S/A |
Rua Waldir Landgraf, 101 |
Londrina,
BR
86.031-218
|
|
Applicant Contact |
Paulo Sergio Calixto de Oliveria |
Correspondent |
Angelus Industria de Produtos Odontologicos S/A |
Rua Waldir Landgraf, 101 |
Londrina,
BR
86.031-218
|
|
Correspondent Contact |
Juliana Norder |
Regulation Number | 872.3820
|
Classification Product Code |
|
Date Received | 01/23/2018 |
Decision Date | 08/31/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|