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510(k) Data Aggregation

    K Number
    K012882
    Device Name
    BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060
    Manufacturer
    THERMOELASTIC TECHNOLOGIES, INC.
    Date Cleared
    2001-11-14

    (78 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060

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

    Intended for Use as a long-term resilient lining material for removable dentures, and to reline, repair, clasp or rebase dentures.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a dental device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the given input. The document is essentially a clearance letter, confirming that the device is substantially equivalent to legally marketed predicate devices, not a detailed study report.

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