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510(k) Data Aggregation

    K Number
    K200652
    Device Name
    Lollipop BiteBlock
    Date Cleared
    2020-07-06

    (116 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    RadTec Medical Devices, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Lollipop BiteBlock from RadTec Medical Devices, Inc. is intended to be used for repeat positioning and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.
    Device Description
    The Lollipop BiteBlock is a multi-configuration, single patient reusable device intended to be used for the planning, positioning, and re-positioning of a patient's oral cavity while they undergo or receive a course of external beam radiation therapy for the treatment of cancer and other diseases. The Lollipop BiteBlock is designed for use in radiation therapy departments in hospitals and/or free-standing treatment centers. The Lollipop BiteBlock is available in four configurations: lateral tongue localization (LTL), mouth open tongue forward (MOTF), mouth open tongue depressed (MOTD), and mouth open tongue (forward) closed (MOTC). The choice of which configuration is appropriate to the patient is left to the physician's discretion. The Lollipop BiteBlock is manufactured using 3D printing technology. At least one sample, per lot, from each of the four configurations is measured to ensure that it meets device specifications. The Lollipop BiteBlock is provided to the physician as the final finished device. The 3D electronic files are not sent to the physician at any time.
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