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510(k) Data Aggregation

    K Number
    K023831
    Device Name
    UCP DENTAL MATERIAL
    Manufacturer
    PRECIOUS CHEMICALS U.S.A., INC.
    Date Cleared
    2003-01-24

    (67 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The UCP™ Dental Material is used as a bonding agent to facilitate a bond between an opaque porcelain and a gold based metal understructure in the preparation of a Porcelain-Fused-to-Metal-Restoration (PFM). The UCP™ Dental Material is particularly intended for bonding porcelain to a precious metal coping marketed under the trade name "Captek" which received Premarket 510(k) authorization from the FDA in 1994 under the FDA number K932243 HF-2-410 ODE/DGRD.

    Device Description

    UCP™ Dental Material

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental material. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of an AI/algorithm-based medical device. The document is for a physical dental material (UCP™ Dental Material) used as a bonding agent, not an AI device.

    Therefore, I cannot provide the requested information from the provided text.

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