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    K Number
    K040859
    Device Name
    HERACERAM PRESS
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    2004-05-20

    (48 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HERACERAM PRESS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HeraCeram Press dental ceramic compound is intended for use with the veneering ceramic material HeraCeram. It can be used for full ceramic restorations with the common layering technique as well as the staining technique. Applications: Veneers, Inlays, Onlays and Crowns.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Heraeus Kulzer, Incorporated, regarding their device "HeraCeram Press." It primarily discusses the substantial equivalence determination for this dental ceramic compound.

    This document does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, ground truth establishment, or clinical study results (such as MRMC or standalone performance). The letter is a regulatory approval document and not a performance study report.

    Therefore, I cannot fulfill your request for detailed information on acceptance criteria and study particulars based on the provided text.

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