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510(k) Data Aggregation

    K Number
    K040043
    Device Name
    NDX-40 ALLOY
    Date Cleared
    2004-03-03

    (51 days)

    Product Code
    Regulation Number
    872.3060
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NDX-40 ALLOY

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

    ¾ and single crowns, inlays, veneer crowns and short span bridges.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental device called "NDX-40." It does not contain information about acceptance criteria, study design, or performance data beyond the device's indications for use. Therefore, I cannot generate the requested table and study details.

    The document indicates:

    • Device Name: NDX-40
    • Indications For Use: "¾ and single crowns, inlays, veneer crowns and short span bridges."
    • Regulation Number: 21 CFR 872.3060 and 21 CFR 872.5000 (Gold Based Alloys and Precious Metal Alloys for Clinical Use)
    • Regulatory Class: II
    • Product Code: EJT

    To provide the information you requested, I would need a different document, such as the actual 510(k) summary or a clinical study report that details the performance testing of the NDX-40.

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