K232182 is an FDA 510(k) clearance for the One-Fil. This device is classified as a Resin, Root Canal Filling (Class II - Special Controls, product code KIF).
Submitted by Mediclus Co., Ltd. (Cheongju-Si, KR). The FDA issued a Cleared decision on January 26, 2024, 186 days after receiving the submission on July 24, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.
| 510(k) Number | K232182 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2023 |
| Decision Date | January 26, 2024 |
| Days to Decision | 186 days |
| Submission Type | Traditional |
| 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 |