Vioseal X
FDA 510(k) K262050 · Spident Co., Ltd.
510(k) numberK262050
Submission
- Device name
- Vioseal X
- Applicant
- Spident Co., Ltd.
Incheon, KR - Received
- June 18, 2026
- Decision date
- September 11, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K251884 | One-Fil Putty InjectableKIF · Special | Mediclus Co., Ltd. | 08/22/2025SE |
| 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 |
|---|---|---|
| K261129 | OrthoFitDYH · Traditional | 07/02/2026SE |
| K250566 | EsCem RMGIEMA · Traditional | 06/20/2025SE |
| K250317 | EsFlow PLUSEBF · Traditional | 05/30/2025SE |
| K242702 | VioSealKIF · Traditional | 11/07/2024SE |
| K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml…KLE · Traditional | 11/01/2024SE |
| K241445 | K-Bond UniversalKLE · Traditional | 07/22/2024SE |
| K231523 | EsCom250EBF · Traditional | 07/24/2023SE |
| K214076 | EsCemEMA · Traditional | 12/19/2022SE |
| K214071 | Hexa-TempEBG · Traditional | 03/10/2022SE |
| K161774 | i-SilELW · Traditional | 09/30/2016SE |
Questions and answers
When was Vioseal X cleared by the FDA?
Vioseal X (K262050) received a 510(k) decision of Substantially Equivalent on September 11, 2026, 85 days after the submission was received.
What is the product code of K262050?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.