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510(k) Data Aggregation

    K Number
    K013609
    Device Name
    NEXUS 2 CLEAR
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    2002-01-16

    (77 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Nexus 2 Clear is a dual cured, resin-based, dental cement designed to be used for luting inlays, onlays, crowns, bridges, porcelain veneers and endodontic posts.

    Device Description

    Nexus 2 Clear is a dual cured, chemical and light cured, dental cement designed to be used for luting inlays, onlays, crowns, bridges, porcelain veneers and endodontic posts. Nexus 2 Clear is a two-part, base/catalyst - paste/paste, system.

    AI/ML Overview

    This document is a 510(k) premarket notification for a dental luting cement, Nexus 2 Clear. It does not contain information on acceptance criteria for a device's performance, nor does it describe a study proving such criteria are met. The document focuses on establishing substantial equivalence to a predicate device based on similar materials, intended use, and functional characteristics, which is a regulatory pathway, not a performance study as typically understood for AI/ML or diagnostic devices.

    Therefore, I cannot provide the requested information. The document pertains to a traditional medical device (dental cement) and its regulatory submission, not a study evaluating a device's performance against pre-defined acceptance criteria in the context of clinical outcomes or AI model accuracy.

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