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510(k) Data Aggregation

    K Number
    K052543
    Device Name
    HERACERAM ZIRKONIA
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    2005-10-25

    (40 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 ZIRKONIA

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

    HeraCeram Zirkonia dental ceramic compound is intended for use with the rieraeona crown and bridge framework made of zirconia.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets those criteria.

    The document is a US FDA 510(k) clearance letter for a dental ceramic product called "HeraCeram Zirkonia." This letter primarily addresses the substantial equivalence of the device to a legally marketed predicate device and outlines regulatory requirements. It does not contain:

    • A table of acceptance criteria or reported device performance.
    • Details about sample sizes for test sets or their data provenance.
    • Information on experts used to establish ground truth.
    • Adjudication methods.
    • Results of any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
    • Information about standalone algorithm performance.
    • The type of ground truth used (e.g., pathology, outcomes data).
    • Sample sizes for training sets and how their ground truth was established.

    These types of details would typically be found in the 510(k) submission itself, which is a much more extensive document than the clearance letter provided. The clearance letter only states that the device was found "substantially equivalent" based on the information in the submission.

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