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510(k) Data Aggregation

    K Number
    K990078
    Device Name
    D-SIGN IV (R&D PROJECT DW265#37)
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    1999-02-12

    (32 days)

    Product Code
    EJS,ETS
    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

    Indications for Use: D-Sign is to be used with conventional feldpathic porcelains. Also recommended for 3/4 crowns, telescop crowns, conus porcerains. Inco recoments, short and long span bridges, PFM crowns.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental device called "D-Sign IV". The letter states that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or specifics about ground truth for training or testing sets. These details are typically found in the substantial equivalence report or technical documentation submitted with the 510(k) application, not in the clearance letter itself.

    Therefore, I cannot provide the requested information based on the given input. The document confirms market clearance based on substantial equivalence, but it does not detail the technical study results or performance metrics.

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