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510(k) Data Aggregation

    K Number
    K990235

    Validate with FDA (Live)

    Device Name
    D-SIGN VI (R&D PROJECT DW266#9)
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    1999-03-01

    (35 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    D-Sign VI 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

    The provided text is a scanned letter from the FDA regarding a 510(k) premarket notification for a device called "D-Sign VI." It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or AI assistance.

    Therefore, I cannot answer your request based on the provided input. The document is simply an FDA clearance letter, not a detailed technical report or study summary.

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