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510(k) Data Aggregation

    K Number
    K972534
    Device Name
    ALFALLOY
    Manufacturer
    AALBA DENT, INC.
    Date Cleared
    1997-09-05

    (60 days)

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

    ALFALLOY

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

    This device is a "white" colored, casting alloy for use in full coverage and onlay prosthetic devices.

    Device Description

    "white" colored, casting alloy

    AI/ML Overview

    The provided FDA letter and associated documents for K972534, "White" Colored, Casting Alloy, do NOT contain the information necessary to describe acceptance criteria or a study proving device performance as requested.

    This document is a 510(k) clearance letter, which states that the device is substantially equivalent to a predicate device already on the market. It does not typically include detailed performance study results or acceptance criteria for a new device.

    Therefore, I cannot provide the requested table or answer the specific questions regarding performance studies, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is not part of this specific FDA communication.

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