K190537 is an FDA 510(k) clearance for the BIO-C Sealer Ion+. This device is classified as a Resin, Root Canal Filling (Class II - Special Controls, product code KIF).
Submitted by Angelus Industria DE Produtos Odontologicos S/A (Londrina, BR). The FDA issued a Cleared decision on December 12, 2019, 283 days after receiving the submission on March 4, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.
| 510(k) Number | K190537 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2019 |
| Decision Date | December 12, 2019 |
| Days to Decision | 283 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KIF - Resin, Root Canal Filling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3820 |