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510(k) Data Aggregation

    K Number
    K982394
    Manufacturer
    Date Cleared
    1998-09-21

    (74 days)

    Product Code
    Regulation Number
    872.3200
    Panel
    Dental
    Reference & Predicate Devices
    Why did this record match?
    Reference Devices :

    K962348, K964525

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

    Direct composite and compomer restorations; Composite, ceramic and amalgam repairs; Cavity varnish for use with fresh amalgam; Indirect restorations-dual cure, inlays, onlays, veneers, crowns and bridges; Endodontic post cementation; and Adhesive bonding of direct amalgam restorations.

    Device Description

    PRIME & BOND® NT™ BONDING AGENT is a one-component, no-mix visible light-curable dental bonding agent that contains fluoride. When used with the activator provided (K964525), the bonding agent may be self-cured or dual-cured.

    AI/ML Overview

    The provided text is a 510(k) summary for a dental adhesive system, not an AI/ML device. Therefore, it does not contain information related to AI/ML specific acceptance criteria, study designs, sample sizes for test/training sets, expert ground truth adjudication, or metrics like accuracy, sensitivity, and specificity that would be used to evaluate an AI/ML device.

    The document discusses the substantial equivalence of the "PRIME & BOND® NT™ DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM" to predicate devices based on physical properties and biocompatibility testing. The "performance data" mentioned refers to these physical properties and biocompatibility, not AI/ML performance metrics.

    As such, I cannot populate the requested table or answer the questions related to AI/ML device evaluation criteria.

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