K243353 is an FDA 510(k) clearance for the One-Fil Putty. 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 March 14, 2025, 136 days after receiving the submission on October 29, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.
| 510(k) Number | K243353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2024 |
| Decision Date | March 14, 2025 |
| Days to Decision | 136 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 |