Cavitron® 8800101Recalls & 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. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D00388001011), received between Apr 16, 2026 and Apr 16, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Overheating of Device” (1 report).
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 Device1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2026Overheating of Device
WHILE THE CUSTOMER WAS USING A G139, THEY ALLEGE THAT THE HANDPIECE GOT REALLY HOT SITTING IN THE HOLDER. ALLEGEDLY, THE HYGIENIST BURNED HER HAND PICKING IT UP.
Patient problems: Burn(s)
MAUDE report 24896536 ↗
Other Scaler, ultrasonic devices
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- 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 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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