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510(k) Data Aggregation

    K Number
    K173163
    Device Name
    ChlorCid, ChlorCid V, ChlorCid Surf
    Manufacturer
    Ultradent Products, Inc.
    Date Cleared
    2018-02-09

    (133 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K060335,K082470
    Why did this record match?
    Device Name :

    ChlorCid, ChlorCid V, ChlorCid Surf

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

    ChlorCid, ChlorCid V and ChlorCid Surf are used for irrigating, instrumentation and debriding of root canal preparations.

    Device Description

    The ChlorCid family of products are aqueous solutions of 3% sodium hypochlorite used for endodontic procedures. When desired, ChlorCid V is a more viscous solution for enhanced flow control and lubrication, and ChlorCid Surf includes a surfactant which assists in the product's ability to penetrate in tight canal spaces.

    AI/ML Overview

    This document is a 510(k) premarket notification for dental devices (ChlorCid, ChlorCid V, ChlorCid Surf), which are root canal cleansers. It asserts substantial equivalence to predicate devices, and therefore, does not contain details of an AI/ML-based device or a comparative effectiveness study involving AI assistance.

    The document describes material properties, such as concentration, pH, viscosity, and wettability, and "simulated root canal" and "extracted molars" tests to demonstrate performance of the device. It focuses on chemical and physical properties and their functional relevance, rather than diagnostic accuracy or human-AI interaction.

    Therefore, I cannot provide the information requested in your prompt as it pertains to AI/ML device acceptance criteria and study designs (e.g., sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.). The provided document is for a traditional medical device (chemical solution) and its substantial equivalence filing, not a software as a medical device (SaMD) or an AI-enabled device.

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