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510(k) Data Aggregation

    K Number
    K042846

    Validate with FDA (Live)

    Device Name
    SYSTEMP.LINK
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2004-12-20

    (66 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    K160443
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For the temporary cementation of temporary inlays, partial crowns, crowns or bridges. The retention period should not last longer than 8 weeks.

    Device Description

    Not Found

    AI/ML Overview

    This set of documents describes an FDA 510(k) clearance for a dental cement, Systemp.link. The content is primarily an FDA letter and an "Indications for Use" form. It does not include information about acceptance criteria, device performance studies, or any of the other specific study-related details requested in the prompt.

    Therefore, I cannot fulfill the request using only the provided information. The document is a regulatory approval, not a technical report detailing study results.

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