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510(k) Data Aggregation

    K Number
    K980799
    Device Name
    HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
    Manufacturer
    COSMEDENT, INC.
    Date Cleared
    1998-10-28

    (240 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Used for temporary restorations.

    Device Description

    High Viscosity Composite Temporary (Provisional) Material

    AI/ML Overview

    This document is a letter from the FDA to Cosmedent, Incorporated regarding their 510(k) premarket notification for a "High Viscosity Composite Temporary Material." It primarily discusses the regulatory approval of the device based on its substantial equivalence to previously marketed devices.

    Therefore, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

    The letter is a regulatory approval document and does not detail the technical performance or testing of the device. Consequently, I cannot populate the requested table or answer any of the questions about the study design, sample sizes, expert qualifications, or ground truth.

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