LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K232393
    Device Name
    BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge
    Manufacturer
    ProEdge Dental Products, Inc.
    Date Cleared
    2023-10-27

    (79 days)

    Product Code
    QYJ,EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K992893
    Why did this record match?
    Product Code :

    QYJ

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

    The BluTube@Dental Unit Water Purification Cartridge is for use on dental unit water lines attached to the dynamic dental instruments, i.e., high-speed handpiece, three-way airwater syringe and ultrasonic scaler. This cartridge in conjunction with currently recommended practices regarding sterilization and flushing of dental instruments reduces bacteria from the water supplied to the instruments to less than 200 CFU/mL, a level that will meet or exceed the current American Dental Association (ADA) recommendations for water quality.

    Device Description

    BluTube® is a dental unit waterline purification cartridge intended for use at dental offices to reduce microbial bioburden in dental unit waterlines (DUWLs). BluTube® is placed in-line with the pick-up tube of the water supply bottle of a dental operative unit (DOU). Once installed, water flows into the device and through the iodinated resin chamber. Bacterial populations in the treated water are reduced through the antimicrobial action of iodine, which is released from the iodinated resin and into the treated water. Treated water expelled from BluTube® can be used as an irrigant/coolant for nonsurgical dental procedures and is appropriate for use in dental instruments like air/water syringes or high-speed handpieces.

    AI/ML Overview

    The FDA 510(k) summary for the BluTube® Dental Unit Water Purification Cartridge (K232393) describes the acceptance criteria and the study that proves the device meets them. This device is intended to reduce bacterial populations in dental unit waterlines (DUWLs).

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Antimicrobial Efficacy: Reduce bacteria from the water supplied to dental instruments to less than 200 CFU/mL, meeting or exceeding current American Dental Association (ADA) recommendations for water quality.Under simulated use conditions (≥ 120 L of water treated), bacterial concentrations in DUWL water treated by BluTube® and the predicate device (Dentapure DP365B) were **
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1