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510(k) Data Aggregation

    K Number
    K053060
    Device Name
    TCS UNBREAKABLE
    Manufacturer
    THERMOPLASTIC COMFORT SYSTEMS, INC.
    Date Cleared
    2006-07-20

    (262 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K113608,K113788,K123220,K142894,K152270,K250617,K242897
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TCS® Unbreakable is a break resistant material used in the fabrication and repair of base plates for removeable dental prosthetic appliances where superior flexibility and patient comfort for the lifetime of the prosthetic are significant concerns. This includes, but not to be limited to, full and partial dentures, orthodontic devices, occlusal splints, and night guards.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) substantial equivalence letter from the FDA for a dental material (TCS® Unbreakable) and does not contain information about acceptance criteria or a study proving that a device meets such criteria.

    Therefore, I cannot fulfill the request to provide:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set and data provenance.
    3. Number of experts used to establish ground truth and their qualifications.
    4. Adjudication method.
    5. MRMC comparative effectiveness study details.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Training set sample size.
    9. How ground truth for the training set was established.
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