LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K030632
    Device Name
    PD CASTA-H
    Manufacturer
    MOUNTAIN MEDICO, INC.
    Date Cleared
    2003-05-07

    (68 days)

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

    PD CASTA-H

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

    Non-Precious Dental Casting Alloy . Suitable for use in fabrication of removable dental appliances.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a dental casting alloy, not a study evaluating an AI-enabled medical device. Therefore, it does not contain information related to acceptance criteria, study methodologies, or AI performance metrics as requested in the prompt.

    Specifically, the document establishes the substantial equivalence of the "PD Casta-H" device to legally marketed predicate devices, allowing it to be marketed. This process does not involve the type of performance evaluation, ground truth establishment, or statistical analysis typically associated with AI device studies.

    Therefore, I cannot provide the requested information based on the given document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1