Well-Root PT
FDA 510(k) K252285 · Vericom Co., Ltd.
510(k) numberK252285
Submission
- Device name
- Well-Root PT
- Applicant
- Vericom Co., Ltd.
Chuncheon-Si, KR - Received
- July 23, 2025
- Decision date
- September 19, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K260805 | Dual CoreEBF · Traditional | 05/11/2026SE |
| K203672 | MAZIC Claro CAD and MAZIC Claro PressEIH · Traditional | 07/01/2021SE |
| K193260 | U-Cem Premium & MAZIC CemEMA · Traditional | 08/21/2020SE |
| K170950 | Well-Root STKIF · Traditional | 12/20/2017SE |
| K163346 | MAZIC DuroEBF · Traditional | 03/17/2017SE |
| K160377 | V-varnish PremiumLBH · Traditional | 12/02/2016SE |
| K152615 | Vonflex SELW · Traditional | 11/03/2016SE |
| K152518 | Vonflex S PuttyELW · Traditional | 11/30/2015SE |
| K140966 | Vonflex S BiteELW · Traditional | 08/15/2014SE |
| K103164 | Vonflex Heavy, Vinflex LightELW · Traditional | 11/10/2010SE |
Questions and answers
When was Well-Root PT cleared by the FDA?
Well-Root PT (K252285) received a 510(k) decision of Substantially Equivalent on September 19, 2025, 58 days after the submission was received.
What is the product code of K252285?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.