LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K061689
    Device Name
    AQUATINE EC ENDODONTIC CLEANSER
    Manufacturer
    PURICORE, INC.
    Date Cleared
    2006-08-24

    (70 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K962743,K992919,K053167
    Why did this record match?
    Device Name :

    AQUATINE EC ENDODONTIC CLEANSER

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

    Aquatine™ EC Endodontic Cleanser is intended to irrigate, cleanse and debride root canal systems.

    Device Description

    Aquatine™ EC Endodontic Cleanser irrigates, cleanses and debrides. The mechanical action of the solution moving in the root canal facilitates easy removal of debris and necrotic pulp tissue from the root canal.

    AI/ML Overview

    The Aquatine™ EC Endodontic Cleanser is deemed substantially equivalent based on non-clinical performance and biocompatibility data. The provided document, K061689, does not contain information about specific acceptance criteria or a study with detailed performance metrics, sample sizes, expert involvement, or comparative effectiveness studies that would be typical for an AI/ML powered device. Instead, the clearance is based on the device's similarity in function and intended use to existing legally marketed predicate devices and the fact that all components of Aquatine™ EC have been used in legally marketed devices.

    Therefore, I cannot populate the table or answer the specific questions as the information is not present in the provided text. The document is a 510(k) summary and clearance letter for a non-AI/ML medical device, which explains why these details are absent.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1