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510(k) Data Aggregation

    K Number
    K023790
    Device Name
    UCC DENTAL MATERIAL
    Manufacturer
    PRECIOUS CHEMICALS U.S.A., INC.
    Date Cleared
    2003-01-21

    (69 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K932243
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The UCC™ Dental Material is used as a bonding agent to facilitate a bond between an opaque resinous veneering material and a gold based metal understructure in the preparation of a Resin-Fused-to-Metal-Restoration (RFM). The UCC™ Dental Material is particularly intended for bonding veneering material 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

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental material (UCC™ Dental Material). It confirms substantial equivalence to a predicate device but does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to the efficacy or performance testing of the device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided text. The document focuses solely on the regulatory approval process based on substantial equivalence, not on a detailed performance study.

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