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510(k) Data Aggregation

    K Number
    K992023
    Device Name
    GRAND CERAM
    Manufacturer
    NORITAKE CO., INC.
    Date Cleared
    1999-09-03

    (79 days)

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

    GRAND CERAM

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

    For use in prosthetic dentistry to create an all-ceramic prosthesis.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental ceramic product called "Grand Ceram." This document does not contain information related to the acceptance criteria, study details, or performance metrics of a device as typically found in a clinical or performance study report for AI/ML-based medical devices.

    The letter confirms that "Grand Ceram" is substantially equivalent to a legally marketed predicate device, indicating it's a conventional material rather than a software-as-a-medical-device (SaMD) or an AI-enabled device that would require the kind of detailed performance study you're asking about.

    Therefore, I cannot extract the requested information (acceptance criteria, sample sizes, ground truth establishment, MRMC study details, etc.) from this document. The document primarily focuses on regulatory clearance for a dental material based on substantial equivalence.

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