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510(k) Data Aggregation

    K Number
    K061337
    Device Name
    WIEDENT ESTETIC
    Manufacturer
    Date Cleared
    2006-06-07

    (26 days)

    Product Code
    Regulation Number
    872.3590
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    WIEDENT ESTETIC

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

    Acrylic teeth to be used for construction of full and partial dentures by a dental professional. Dentures are removable, not implanted in patients' mouths.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance. The document is a 510(k) clearance letter from the FDA for a device called "Wiedent Esthetic Teeth."

    This type of letter primarily focuses on:

    • Substantial Equivalence: It states that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or if there are differences, those differences do not raise new questions of safety and effectiveness.
    • Regulatory Classification: It clarifies the device's regulatory class and product code.
    • Compliance Requirements: It reminds the manufacturer of their ongoing responsibilities under the Federal Food, Drug, and Cosmetic Act.

    The document does not include:

    • Specific acceptance criteria for the device's performance (e.g., tensile strength, wear resistance, color stability).
    • Details of any performance studies conducted to meet such criteria.
    • Information on sample sizes, data provenance, expert qualifications, ground truth establishment, or comparative effectiveness studies.

    Therefore, I cannot populate the table or provide the requested study details from the text you provided.

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