Well-Pex
FDA 510(k) K080266 · Vericom Co., Ltd.
510(k) numberK080266
Submission
- Device name
- Well-Pex
- Applicant
- Vericom Co., Ltd.
Anyang-Si, Gyeonggi-Do, KR - Received
- February 1, 2008
- Decision date
- February 6, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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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 |
| 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 |
More from Voco GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K260805 | Dual CoreEBF · Traditional | 05/11/2026SE |
| K252285 | Well-Root PTKIF · Traditional | 09/19/2025SE |
| 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 |
Questions and answers
When was Well-Pex cleared by the FDA?
Well-Pex (K080266) received a 510(k) decision of Substantially Equivalent on February 6, 2008, 5 days after the submission was received.
What is the product code of K080266?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.