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510(k) Data Aggregation

    K Number
    K994357
    Device Name
    BITEM LOCK, MODELS SW006, SW012
    Manufacturer
    THERMOELASTIC TECHNOLOGIES, INC.
    Date Cleared
    2000-03-14

    (78 days)

    Product Code
    EJF
    Regulation Number
    872.5410
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K900678
    Why did this record match?
    Product Code :

    EJF

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

    Intended for Use as an aligning bracket for removable dentures, and to aid in securing dentures.

    Device Description

    The BITEM LOCK product is a thermo-adjustable alignment bracket with the same use as the predicate device. The only difference is the predicate device is Made from metal and this device is a thermo-adjustable material. The base materials for the BITEM LOCK include a methacrylate liquid, a phthalate plasticizer, an EGDMA cross linker and polymer powder. They are ready made for clinical application.

    AI/ML Overview

    This document, an FDA 510(k) Summary for the BITEM LOCK orthodontic appliance, does not contain information related to acceptance criteria, a study proving device performance against such criteria, or any details about software algorithm performance.

    The provided text focuses on:

    • Device identification: Trade name, classification, submitter, and contact information.
    • Predicate device comparison: Highlighting the BITEM LOCK's similarity in intended use and application to the predicate device (K900678 Myloc System Winder Research). The key difference noted is the material (thermo-adjustable vs. metal) and method of securing it.
    • Intended use: Clearly stating its application as an alignment bracket for removable dentures and to aid in securing dentures.
    • FDA determination: A letter from the FDA confirming substantial equivalence to a legally marketed predicate device, allowing the device to be marketed.

    Therefore, I cannot provide the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or MCRM/standalone study details because this content is not present in the provided text. The device described is a physical orthodontic appliance, not a software or AI-based medical device.

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