Cavitron® 8800001Recalls & reported problems
Dentsply Professional · Cavitron® integrated systems Built-In Ultrasonic Scaler Model G139 Dealer Kit (66 GRAY, S/M 360) Also contains: Handpiece with swivel cable, Ultrasonic insert, Installation kit and Power Supply. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 D00388000011), received between Apr 24, 2024 and Jul 1, 2026 — 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
Most reported problems
Device problems
- Overheating of Device4
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.
MalfunctionJul 1, 2026Overheating of Device
WHILE THE CUSTOMER WAS USING A66 GREY W/STERI-MATE, THEY ALLEGE THAT "INSERT IS GETTING HOT WHEN USING THE UNIT. NO PATIENTS/STAFF HURT". NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25676474 ↗MalfunctionJan 27, 2026Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 66 GREY W/STERI-MATE AND INSERT ALLEGEDLY GOT HOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24188702 ↗MalfunctionAug 27, 2025Overheating of Device; Overheating of Device
WHILE THE CUSTOMER WAS USING A CAVITRON BUILT IN G139, THEY ALLEGE THAT THERE IS A BURNING SMELL, AND THE HANDPIECE AND INSERT ARE HOT. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22905534 ↗MalfunctionApr 24, 2024Overheating of Device; Overheating of Device
WHILE THE CUSTOMER WAS USING A CAVITRON INTEGRATED BUILT-IN SYSTEM ULTRASONIC SCALER G139 THEY ALLEGE THAT THE HANDPIECE AND INSERTS ARE GETTING VERY WARM. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19175396 ↗
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- Cavitron® 8184001Dentsply Professional · Scaler, ultrasonic49 reports
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- Cavitron® 80395Dentsply Professional · Scaler, ultrasonic36 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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