Cavitron® 8800701Recalls & reported problems
Dentsply Professional · Cavitron® integrated systems Built-In Module Assembly - Spare Part Kit MidMark Model G139 · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI D00388007011), received between May 13, 2024 and Jul 28, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (5 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
Most reported problems
Device problems
- Overheating of Device5
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Burn(s)1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A SCALER MODULE ASSY, COMPLETE ALLEGEDLY THE GOT HOT AND THE HYGIENIST SUFFERED A BURN TO THE FINGER AND A PATIENT HAD A BURN TO THEIR TONGUE. NO SERIOUS INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: Burn(s)
MAUDE report 22635966 ↗MalfunctionSep 11, 2024Overheating of Device; Overheating of Device
WHILE THE CUSTOMER WAS USING A CAVITRON INTEGRATED SYSTEM BULIT IN ULTRASONIC SCALER G139 THEY ALLEGE THAT THE TIPS WERE HEATING UP DURING USE. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20191870 ↗MalfunctionSep 11, 2024Overheating of Device; Overheating of Device
WHILE THE CUSTOMER WAS USING A CAVITRON INTEGRATED SYSTEM BUILT IN ULTRASONIC SCALER G139, THEY ALLEGE THAT THE TIP IS HEATING UP DURING USE. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20191660 ↗MalfunctionSep 11, 2024Overheating of Device; Overheating of Device
WHILE THE CUSTOMER WAS USING A CAVITRON INTEGRATED SYSTEM BUILTI IN ULTRASONIC SCALER G139, THEY ALLEGE THAT THE TIPS ARE HEATING UP DURING USE. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20191615 ↗MalfunctionMay 13, 2024Overheating of Device; Overheating of Device
WHILE THE CUSTOMER WAS USING A CAVITRON INTEGRATED BUILT-IN SYSTEM ULTRASONIC SCALER G139 THEY ALLEGE THAT THE INSERTS AND THE UNIT ARE GETTING HOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19305597 ↗
Other Scaler, ultrasonic devices
- AIR-FLOW FT-230-2B-302E.M.S. Electro Medical Systems S.A. · Scaler, Ultrasonic3 recalls0 reports
- AIR-FLOW-PIEZON FT-229HF-0B-302E.M.S. Electro Medical Systems S.A. · Scaler, Ultrasonic3 recalls0 reports
- Cavitron® 81302Dentsply Professional · Scaler, ultrasonic67 reports
- Posterior CleanFlow Procedure Instrument with Matrices FG-013-00004Sonendo, Inc. · Scaler, Ultrasonic1 recall0 reports
- APM Procedure Instrument with Matrix FG-003-00011Sonendo, Inc. · Scaler, Ultrasonic1 recall0 reports
- Cavitron® 8184001Dentsply Professional · Scaler, ultrasonic49 reports
- Cavitron® 8161425Dentsply Professional · Scaler, ultrasonic45 reports
- Cavitron® 80395Dentsply Professional · Scaler, ultrasonic36 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.