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510(k) Data Aggregation

    K Number
    K251390
    Device Name
    MTA vpt
    Manufacturer
    VOCO GmbH
    Date Cleared
    2025-07-03

    (59 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MTA vpt

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Indications:

    • Indirect pulp capping
    • Direct pulp capping
    • Pulpotomy, after removal of affected coronal pulp to preserve vitality of remaining pulp tissue
    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a dental device called "MTA vpt" (Root Canal Filling Resin). This letter does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

    The 510(k) clearance process is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy or meet specific performance metrics. Therefore, the details requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are generally not part of a standard 510(k) submission for this type of device.

    To provide information related to your prompt, I would need a different type of document, such as a clinical study report, a performance testing report, or a summary of safety and effectiveness data, which are not included in this FDA clearance letter.

    Based on the provided document, it is not possible to answer your request. The letter confirms the device's clearance based on substantial equivalence, but it does not detail the specific performance data or studies you're asking about.

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