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510(k) Data Aggregation

    K Number
    K040420
    Device Name
    DUCERAM PLUS CERAMIC SYSTEM
    Manufacturer
    DENTSPLY INTL.
    Date Cleared
    2004-03-18

    (29 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K871808
    Predicate For
    K062504
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DUCERAM® PLUS CERAMIC SYSTEM is indicated for veneering metal framework and copings for the preparation of crowns and bridges.

    Device Description

    The DUCERAM® PLUS CERAMIC SYSTEM is a dental ceramic veneering system for metal framework and copings. They are used by dental technicians for the preparation of crowns and bridges. DUCERAM (K871808) includes Dentine, Incisal, Transparent, Correction (add-on), Opaque, Margin, Stain and Glaze Porcelains. DUCERAM® PLUS CERAMIC SYSTEM also includes Shoulder Porcelain, Paste Opaquers, Opal Masses, and Lay Connector Paste.

    AI/ML Overview

    The provided text is a 510(k) Summary for the DUCERAM® PLUS CERAMIC SYSTEM, a dental ceramic veneering system. It does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

    The summary primarily focuses on:

    • Identification: Name, address, contact, date prepared, trade/proprietary name, classification name.
    • Predicate Device: K871808 DUCERAM Metal Ceramic Dental Porcelain System.
    • Device Description: It's a dental ceramic veneering system for metal framework and copings, used by dental technicians for crowns and bridges. It specifies the components included in both the original DUCERAM and the DUCERAM® PLUS SYSTEM.
    • Intended Use: Veneering metal framework and copings for the preparation of crowns and bridges.
    • Technological Characteristics: All components have been used in legally marketed devices. The formulations are very similar to legally marketed devices and have not changed in a way that would adversely affect biocompatibility, thus no additional biocompatibility testing was deemed necessary.
    • Safety and Effectiveness Claim: The manufacturer believes prior use of components, similarity in formulations, and performance data support safety and effectiveness.

    Therefore, I cannot provide the requested information in the format of a table or describe a study, as the input text does not contain such details. This document is a regulatory submission for substantial equivalence based on similarity to a predicate device, not a performance study report.

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