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510(k) Data Aggregation

    K Number
    K974282
    Device Name
    VITALESCENCE
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Date Cleared
    1998-01-29

    (76 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Vitalescence is used for direct and indirect esthetic restorations in anterior and posterior sections.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a product called "Vitalescence." This letter indicates that the product, defined as "Vitalescence," is a dental restorative material used for direct and indirect esthetic restorations in anterior and posterior sections.

    However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any of the other specific details requested in the prompt.

    The document is a regulatory approval notice, not a technical report or study summary. Therefore, based on the provided text, I cannot answer the questions about acceptance criteria and the study proving the device meets them.

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