LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K993474
    Device Name
    DELTAPAL, ALLOY NO. 5161
    Manufacturer
    METALOR DENTAL USA CORP.
    Date Cleared
    1999-12-02

    (49 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use in the Fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges and Implant-supported Prosthesis Substructures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a dental alloy, Deltapal. It confirms the device's substantial equivalence to a legally marketed predicate device.

    The document does not contain information about:

    • Acceptance criteria for device performance.
    • A study proving the device meets acceptance criteria.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number of experts or their qualifications for ground truth.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • How ground truth for the training set was established.

    This document is a regulatory approval letter for a physical material (dental alloy), not a software or AI-driven diagnostic device. Therefore, the types of detailed performance studies and criteria you're asking for are not typically included in such an FDA clearance letter for this kind of product.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1