K180199 is an FDA 510(k) clearance for the BIO-C TEMP. 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 January 4, 2019, 345 days after receiving the submission on January 24, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.
| 510(k) Number | K180199 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2018 |
| Decision Date | January 04, 2019 |
| Days to Decision | 345 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | KIF - Resin, Root Canal Filling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3820 |