MTA vpt Root Canal Filling
by VOCO GmbH
510(k) K251390
Active
Valid until
No date given
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK251390 | Date3 Jul 2025 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- MTA vpt
- 510(k) Number
- FDA product code
- KIF
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3820
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The MTA vpt is a Resin, Root Canal Filling (per OpenFDA nomenclature), designed for use in endodontic procedures. It is a mineral trioxide aggregate-based material formulated to seal and fill root canals, promoting periapical healing and biocompatibility within dental tissues. Its composition supports long-term sealing and biocompatible interaction with surrounding structures.
Supplied as a single-use dental material, the MTA vpt is intended for professional use in clinical settings by trained dental practitioners. It is packaged sterile and requires no additional sterilization. The device adheres to FDA 510(k) clearance and MDR regulatory standards, with a Device Class II classification under OpenFDA. Storage should follow manufacturer guidelines to maintain sterility and efficacy.
Other devices from VOCO GmbH
Questions
AI-generated answers, 18 Sep 2026
What is the MTA vpt specifically designed to do in endodontic procedures, and how does its composition support its intended use?
The MTA vpt is a mineral trioxide aggregate-based material formulated to seal and fill root canals during endodontic procedures. Its composition promotes periapical healing and ensures biocompatibility with dental tissues, which helps maintain long-term sealing and a stable interaction with surrounding structures. This makes it suitable for procedures requiring durable, tissue-friendly root canal filling.
Is the MTA vpt intended for single-use only, and if so, how should it be stored to maintain its sterility and effectiveness?
Yes, the MTA vpt is supplied as a single-use dental material, meaning each package is designed for one clinical procedure. To maintain sterility and efficacy, storage must follow the manufacturer’s guidelines, which are typically provided in the packaging instructions. This ensures the material remains uncontaminated and ready for professional use in clinical settings.
What regulatory pathways has the MTA vpt undergone, and what does this mean for its use in clinical practice?
The MTA vpt has obtained FDA 510(k) clearance and adheres to MDR (Medical Device Regulation) standards, confirming its compliance with stringent safety and performance requirements. This regulatory approval indicates that the device has been evaluated for substantial equivalence to a predicate device and meets the necessary criteria for use in clinical practice by trained dental practitioners.
Does the MTA vpt require any additional sterilization before use, and why is this important?
No, the MTA vpt is packaged sterile and does not require additional sterilization before use. This is important because it ensures the material remains uncontaminated, reducing the risk of infection and maintaining its intended biocompatibility and sealing properties during endodontic procedures.