The following data is part of a premarket notification filed by Angelus Industria De Produtos Odontologicos S/a with the FDA for Bio-c Sealer Ion+.
| Device ID | K190537 |
| 510k Number | K190537 |
| Device Name: | BIO-C Sealer Ion+ |
| Classification | Resin, Root Canal Filling |
| Applicant | Angelus Industria De Produtos Odontologicos S/A Rua Waldir Landgraf, 101 Londrina, BR 86.031-218 |
| Contact | Paulo Sergio Calixto De Oliveira |
| Correspondent | Juliana Norder Trostdorf Angelus Industria De Produtos Odontologicos S/A Rua Waldir Landgraf, 101 Londrina, BR 86.031-218 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-04 |
| Decision Date | 2019-12-12 |