One-Fil Putty Injectable
FDA 510(k) K251884 · Mediclus Co., Ltd.
510(k) numberK251884
Submission
- Device name
- One-Fil Putty Injectable
- Applicant
- Mediclus Co., Ltd.
Cheongju-Si, KR - Received
- June 20, 2025
- Decision date
- August 22, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262050 | Vioseal XKIF · Traditional | Spident Co., Ltd. | 09/11/2026SE |
| K253909 | NeoPEX Pre-Mixed Obturation PasteKIF · Traditional | NuSmile, Ltd. | 09/04/2026SE |
| K261514 | Calcium Hydroxide Temporary Filling Material (KP-Cal)KIF · Traditional | Guilin Kevin Peter Technology Co., Ltd. | 08/25/2026SE |
| K261415 | Injectable Root Canal Sealer (KP-Root SP)KIF · Traditional | Guilin Kevin Peter Technology Co., Ltd. | 06/29/2026SE |
| K253167 | Any-PasteKIF · Traditional | Mediclus Co., Ltd. | 01/12/2026SE |
| K252890 | ZenSeal ProKIF · Traditional | Kerr Corporation | 01/07/2026SE |
| K251465 | Root canal repair materials (nRoot BP)KIF · Traditional | Enpuno Biotechnology Co., Ltd. | 09/25/2025SE |
| K252285 | Well-Root PTKIF · Traditional | Vericom Co., Ltd. | 09/19/2025SE |
| K251390 | MTA vptKIF · Traditional | Voco GmbH | 07/03/2025SE |
| K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP)KIF · Traditional | Enpuno Co., Ltd. | 06/11/2025SE |
More from Enpuno Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K262074 | Any-ZircosEIH · Traditional | 08/21/2026SE |
| K254201 | Any-CemEMA · Traditional | 08/13/2026SE |
| K261728 | One-Fil LCEJK · Traditional | 07/21/2026SE |
| K260485 | Any-EtchKLE · Traditional | 05/14/2026SE |
| K260819 | Any-Com SealEBC · Traditional | 05/01/2026SE |
| K253797 | One-StopMVL · Traditional | 02/27/2026SE |
| K253167 | Any-PasteKIF · Traditional | 01/12/2026SE |
| K252465 | Any-CoreEBF · Traditional | 12/05/2025SE |
| K251283 | Once-Fil FlowEBF · Traditional | 06/06/2025SE |
| K250823 | Any-Com FlowEBF · Special | 04/14/2025SE |
Questions and answers
When was One-Fil Putty Injectable cleared by the FDA?
One-Fil Putty Injectable (K251884) received a 510(k) decision of Substantially Equivalent on August 22, 2025, 63 days after the submission was received.
What is the product code of K251884?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.