LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K993508
    Device Name
    V-SUPRA PLUS, ALLOY NO. 5025
    Manufacturer
    METALOR DENTAL USA CORP.
    Date Cleared
    1999-12-06

    (52 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K023197,K023200
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental device, "V-Supra Plus," and an "Indications for Use" statement. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt.

    Therefore, I cannot populate the table or answer the questions based on the provided text. This document is purely regulatory in nature, indicating that the device has been deemed "substantially equivalent" to predicate devices and can be marketed. It does not include the technical study results or performance metrics you are asking for.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1