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510(k) Data Aggregation

    K Number
    K231388
    Device Name
    NextDent Base
    Manufacturer
    Vertex-Dental B.V.
    Date Cleared
    2023-10-20

    (161 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    K191497
    Why did this record match?
    Device Name :

    NextDent Base

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

    NextDent Base is for dental professional use only and intended for the manufacturing of denture bases to support artificial teeth to form full or partial removable dentures.

    Device Description

    Light-Cure Resin, provided in a container. NextDent Base is a combination of acrylate-based light-cure resin with pigments, polymerized via photo initiators in a 3D printer setting for fabrication of denture bases to support artificial teeth to form full or partial removable dentures. Fabrication of denture bases with NextDent Base requires a VAT based 3D printer that supports NextDent resins. Printer and resin must be optimized to each other to get complete and precise printed parts.

    AI/ML Overview

    The provided document is a 510(k) summary for a dental device called "NextDent Base." It describes the device, its intended use, and a summary of testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria for a specific AI-powered medical device, nor does it present a study proving an AI device meets such criteria.

    The document is solely about a dental material (resin for denture bases) and its mechanical and biological safety testing against established ISO standards for dental polymers. There is no mention of AI, machine learning, or software performance in the context of device acceptance or a study.

    Therefore, I cannot fulfill your request for an AI device's acceptance criteria and a study proving it meets them based on the provided text. The questions you've asked are designed for AI/software as a medical device (SaMD) submissions, which this document is not.

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