BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON 300 SERIES G310SCLR(DNA)

    MDR report key: 22349710 · Received June 27, 2025

    Report

    Report Number
    2424472-2025-00088
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Report Date
    September 8, 2025
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D00382703111
    PMA / PMN Number
    K150535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE LACK OF WATER FLOW HAS CAUSED AN OVERHEATING INSERT. SINCE AN OVERHEATING INSERT COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803.THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    EDH DSP/IF/IC/SCAN BOARD DAMAGED. ALL THE ACCESSORIES WERE RECEIVED FOR EVALUATION. UNIT HAS A DAMAGED DISPLAY PCB, DISTORTED SCREEN AND FROZEN DISPLAY, DIRTY WATER FILTER. REPLACED THE LISTED PARTS, CHECKED UNIT FOR PERFORMANCE, CLEANED AND FINAL TEST. QA/JB. DHR REVIEW IS NOT REQUIRED BECAUSE THE PRODUCT WAS RETURNED FOR EVALUATION, AND THE DESCRIBED FAILURE MODE IS A KNOWN HAZARD.

    Description of Event or Problem · 0

    WHILE THE CUSTOMER WAS USING A CAVITRON 300 SERIES G310, THEY ALLEGE THAT THEY HAVE LOW WATER FLOW AND THE HANDPIECE IS HEATING UP. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1802837 CAVITRON 300 SERIES G310SCLR(DNA) SCALER, ULTRASONIC ELC DENTSPLY LLC D00382703111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown