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510(k) Data Aggregation

    K Number
    K984037
    Device Name
    CORE-IDE
    Manufacturer
    ROYDENT DENTAL PRODUCTS, INC.
    Date Cleared
    1999-02-04

    (84 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CORE-IDE

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

    DC-Core / Core-Ide is a self cure micro hybride composite for endodontic post cementations and core build-ups (see enclosed Instruction for Use, MSDS).

    Device Description

    The chemistry of DC-Core / Core-Ide P. L. Superior GmbH distributes for Roydent is commonly used in current dental materials. The purpose of this material for use by the dentist is to clinically build up human teeth (restauration in the case of mostly destroyed tooth structure). The material is in general placed against an applied adhesive system.

    AI/ML Overview

    The provided text is a 510(k) summary for the Roydent DC-Core / Core-Ide. This document focuses on establishing substantial equivalence to a predicate device based on material composition and intended use, rather than presenting a study demonstrating the device meets specific performance acceptance criteria through quantitative metrics.

    Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truthing, adjudication, MRMC, standalone performance), or training set information.

    The document states: "The chemical composition and use of DC-Core / Core-Ide is substantially equivalent to 'BIS-CORE Core Build Up Composite', a product manufactured and marketed by BISCO Dental Products, ITASCA, ILLINOIS USA." This indicates that the regulatory approval is based on equivalence to an existing device, not on a new study with quantifiable performance metrics against acceptance criteria.

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