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510(k) Data Aggregation

    K Number
    K990077

    Validate with FDA (Live)

    Device Name
    D-SIGN III (R&D PROJECT DW264#7)
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    1999-02-12

    (32 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    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

    Indications for Use: D-Sign III is to be used with conventional feldpathic porcelains. Also recommended for 3/4 crowns, telescop crowns, conus crowns, posts, attachments, 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 III". It establishes substantial equivalence to a legally marketed predicate device but does not contain any information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information. The letter only confirms that the device can be marketed based on its equivalence to existing products.

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