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510(k) Data Aggregation

    K Number
    K132953
    Device Name
    TIDISHEILD
    Manufacturer
    TIDI PRODUCTS, LLC
    Date Cleared
    2014-02-18

    (151 days)

    Product Code
    PEM
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K151123,K160232
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TIDIShield Curing Light Sleves are indicated for used as an accessory to dental instrument. These sleves are non-sterile and are intended for single patient use only.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification for a dental barrier/sleeve device (TIDIShield™ Curing Light Sleeve), not an AI/ML device. Therefore, the concepts of "acceptance criteria," "study," "test set," "training set," "ground truth," "MRMC study," "standalone performance," and "experts" as they relate to AI/ML device evaluations are not applicable to this document.

    The document discusses the regulatory review and approval of a physical medical device. It confirms that the device is "substantially equivalent" to legally marketed predicate devices and is subject to general controls.

    Therefore, I cannot provide the requested information as it is not present or relevant in the provided text.

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