LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K972910
    Device Name
    PORS ON LITE
    Manufacturer
    DEGUSSA CORP.
    Date Cleared
    1997-10-14

    (68 days)

    Product Code
    EJT
    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

    Device Alloy: Porcelain Fused To Metal Crowns -Full Metal Crowns - Bridges of any span length

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental alloy, specifically "PORS ON LITE". This document does not contain information about acceptance criteria, device performance studies, or details relevant to artificial intelligence (AI) devices.

    Therefore, I cannot fulfill your request to describe acceptance criteria and associated study details based on this input text. The information you are looking for (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this regulatory clearance document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1