LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K030416
    Device Name
    CERACAST-V
    Manufacturer
    MOUNTAIN MEDICO, INC.
    Date Cleared
    2003-04-14

    (63 days)

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

    CERACAST-V

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

    Non-Precious Dental Casting Alloy. Suitable for use in the fabrication of Ceramic Fused to Metal (metallo-ceramic) dental restorations.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a dental alloy, Ceracast-V. It does not contain information about acceptance criteria, device performance details, or any study involving AI assistance for medical image analysis. Therefore, I cannot generate the requested information based on the provided input.

    The document is a clearance letter from the FDA, stating that Ceracast-V is substantially equivalent to legally marketed predicate devices for use as a non-precious dental casting alloy in ceramic fused to metal dental restorations. It does not involve any algorithm performance or clinical study data as typically seen with AI/ML-enabled medical devices.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1