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510(k) Data Aggregation

    K Number
    K192392
    Device Name
    DiaPlus
    Manufacturer
    Diadent Group International
    Date Cleared
    2020-05-26

    (266 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K043562
    Predicate For
    K210421
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    As a dentine/enamel total etching bonding system for direct adhesion, it is used in the adhesion of all direct restoration substances.

    • Bonding of direct composite
    • Bonding to composite and set amalgam
    • Bonding of indirect restoration-Porcelain, Composite (Inlays, Onlays, Veneers, Crowns)
    Device Description

    DiaPlus is a photopolymerization type dentine and enamel adhesive as a 5th generation dentine adhesion system that can be applied to all types of composite resin restorations.

    AI/ML Overview

    The provided text details a 510(k) premarket notification for a dental bonding agent named DiaPlus, aiming to demonstrate its substantial equivalence to a legally marketed predicate device (BC Plus).

    However, the document does not contain information about an AI/ML-driven device or an AI/ML-based study with acceptance criteria and associated performance. The 510(k) submission relates to a physical dental bonding agent and its chemical composition, physical properties, and biocompatibility testing. The "study" referenced in the prompt (acceptance criteria, sample sizes, expert ground truth, MRMC, etc.) is consistent with a performance study for an AI/ML medical device, which is not what this document describes.

    Therefore, it's not possible to extract the requested information from the provided text. The document focuses on bench testing and biocompatibility for a dental material, not an AI/ML algorithm.

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