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510(k) Data Aggregation

    K Number
    K042847
    Device Name
    SYSTEMP.CEM
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2004-12-17

    (63 days)

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

    For the temporary cementation of provisional restorations; temporary cementation of permanent restorations during the trial phase. The product has been designed to remain in the mouth for up to 4 weeks.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA for a dental cement called "Systemp.cem". It primarily discusses the substantial equivalence determination for the device, its classification, and regulatory requirements.

    This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).

    Therefore, I cannot provide the requested table and study details.

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