MTA vpt
FDA 510(k) K251390 · Voco GmbH
510(k) numberK251390
Submission
- Device name
- MTA vpt
- Applicant
- Voco GmbH
Cuxhaven, DE - Received
- May 5, 2025
- Decision date
- July 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K251884 | One-Fil Putty InjectableKIF · Special | Mediclus Co., Ltd. | 08/22/2025SE |
| 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 |
|---|---|---|
| K252073 | VOCO Profluorid Varnish + BioMinLBH · Traditional | 05/01/2026SE |
| K261357 | Grandio disc multicolorEBF · Traditional | 04/27/2026SE |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-InEMA · Traditional | 03/20/2026SE |
| K251239 | GrandioSO UnlimitedEBF · Special | 05/21/2025SE |
| K231817 | AlignerFlow LCDYH · Traditional | 12/01/2023SE |
| K231591 | V-Print c&b tempPOW · Traditional | 07/31/2023SE |
| K230877 | Admira Fusion 5EBF · Traditional | 07/13/2023SE |
| K220236 | V-Print dentbaseEBI · Traditional | 09/21/2022SE |
| K220640 | Bifix Hybrid Abutment CementEMA · Traditional | 08/23/2022SE |
| K220743 | CediTECEBI · Traditional | 07/05/2022SE |
Questions and answers
When was MTA vpt cleared by the FDA?
MTA vpt (K251390) received a 510(k) decision of Substantially Equivalent on July 3, 2025, 59 days after the submission was received.
What is the product code of K251390?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.