BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON 300 SERIES G310SCLR(DNA)

    MDR report key: 23967306 · Received January 5, 2026

    Report

    Report Number
    2424472-2025-00180
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Report Date
    January 22, 2026
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D00382703101
    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

    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.

    Additional Manufacturer Narrative · 0

    01/13/2026 EVALUATION TECH: (B)(6). EDH DSP/IF/IC/SCAN BOARD DAMAGED. DISPLAY IS CRACKED ALL AROUND THE EDGES. RAN UNIT FOR 25 MIN WITHOUT ANY ISSUES; INSERTS DIDN'T HEAT UP; I SUGGEST CHECKING YOUR INSERTS AND BE SURE TO USE "30K DENTSPLY SIRONA INSERTS" WHEN USING OUR UNITS. DAMAGED HANDPIECE CABLE; HAS HOLES THROUGHOUT THE CORD. WRONG OR MISSING WATER FILTER AFFECTING WATER QUALITY. WILL REPLACE DAMAGED/WORN COMPONENTS AND RECALIBRATE UNIT TO FACTORY SPECS UPON ESTIMATE APPROVAL. ST: 05/21. HPC: 04/21. 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 THE INSERTS ARE HEATING UP. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29062 CAVITRON 300 SERIES G310SCLR(DNA) SCALER, ULTRASONIC ELC DENTSPLY LLC D00382703101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown