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Cavitron® 8800104Recalls & reported problems

Dentsply Professional · Cavitron® integrated systems Built-In Ultrasonic Scaler Model G139 Dealer Kit (82 GRAY, S/M) Also contains: Handpiece with swivel cable, Ultrasonic insert, Installation kit. · Class 2

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI D00388001041), received between Dec 13, 2023 and Feb 19, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 2 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Overheating of Device4
  • Restricted Flow rate1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 19, 2025Overheating of Device; Overheating of Device

    WHILE THE CUSTOMER WAS USING A CAVITRON INTEGRATED SYSTEM BUILT IN ULTRASONIC SCALER G139, THEY ALLEGE THAT THE HANDPIECE AND THE INSERT TIP GET EXTREMELY HOT. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21417288 ↗
  • MalfunctionJul 24, 2024Overheating of Device; Overheating of Device

    WHILE THE CUSTOMER WAS USING A CAVITRON INTEGRATED SYSTEM BUILT IN ULTRASONIC SCALER G139 THEY ALLEGE THAT THE HANDPIECE AND THE INSERT GOT HOT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19818866 ↗
  • MalfunctionJul 24, 2024Overheating of Device; Overheating of Device

    WHILE THE CUSTOMER WAS USING A G139 THEY ALLEGE THAT THE HANDPIECE IS GETTING HOT AND THE INSERTS ARE MELTING. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19818865 ↗
  • MalfunctionDec 13, 2023Restricted Flow rate; Overheating of Device; Restricted Flow rate; Overheating of Device

    WHILE THE CUSTOMER WAS USING A CAVITRON INTEGRATED SYSTEM BUILT IN ULTRASONIC SCALER G139 THEY ALLEGE THAT THE INSERT GETS REALLY HOT WITH LITTLE WATER. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18317728 ↗

Other Scaler, ultrasonic devices

All Scaler, ultrasonic devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.