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510(k) Data Aggregation

    K Number
    K990182
    Device Name
    D-SIGN V (R&D PROJECT DW267#17)
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    1999-03-01

    (40 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    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 V is to be used with conventional feldpathic porcelains. Also recommended for posts, attachments, short and long span bridges, and PFM crowns.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the D-Sign V device. It does not contain information about acceptance criteria or a study proving device performance.

    The letter confirms that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. It grants permission to market the device, subject to general controls provisions of the Act.

    Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory clearance and substantial equivalence, not on specific performance study details or acceptance criteria.

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