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510(k) Data Aggregation

    K Number
    K972607
    Device Name
    PLATALLOY
    Manufacturer
    AALBA DENT, INC.
    Date Cleared
    1997-10-10

    (91 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PLATALLOY

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

    This device is a "white" colored, casting alloy for use in the construction of dental inlay and onlay prosthetic devices. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872. the classification name for this device is Base Metal Alloy, a Class II device.

    Device Description

    This device is a "white" colored, casting alloy for use in the construction of dental inlay and onlay prosthetic devices.

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy device (Platalloy). It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain information about:

    • Acceptance criteria and reported device performance in a table.
    • Details about any study conducted to prove the device meets acceptance criteria.
    • Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, or training set information.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input.

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