K251884 is an FDA 510(k) clearance for the One-Fil Putty Injectable. 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 August 22, 2025, 63 days after receiving the submission on June 20, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.
| 510(k) Number | K251884 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2025 |
| Decision Date | August 22, 2025 |
| Days to Decision | 63 days |
| Submission Type | Special |
| 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 |