Cavitron® 8270313Recalls & reported problems
Dentsply Professional · Cavitron 300 Series Ultrasonic Scaling System Unit 113v · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI D00382703131), received between Nov 16, 2023 and Dec 28, 2025 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Restricted Flow rate” (7 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
- Restricted Flow rate7
- Overheating of Device5
- No Flow3
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 28, 2025Restricted Flow rate; Overheating of Device; Restricted Flow rate; Overheating of Device
WHILE THE CUSTOMER WAS USING A CAVITRON 300 SERIES G310, THEY ALLEGE THAT THE HANDPIECE AND INSERTS ARE HEATING UP. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23903717 ↗MalfunctionNov 20, 2025Restricted Flow rate; Restricted Flow rate
WHILE USING A CAVITRON 300 SERIES G310, THEY ALLEGE THAT THEY HAVE LOW WATER FLOW AND THE HANDPIECE IS GETTING HOT; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23603966 ↗MalfunctionOct 27, 2025Restricted Flow rate; Restricted Flow rate
WHILE USING A CAVITRON 300 SERIES G310, THEY ALLEGE THAT THEY HAVE LIMITED WATER AN THE HANDPIECE IS HEATING UP; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23395093 ↗MalfunctionOct 23, 2025Restricted Flow rate; Restricted Flow rate
WHILE USING A CAVITRON 300 SERIES G310, THEY ALLEGE THAT THEY HAVE LOW WATER FLOW AND THE HANDPIECE IS HEATING UP, NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23367251 ↗MalfunctionSep 13, 2024Restricted Flow rate; No Flow; Restricted Flow rate; No Flow
WHILE USING A CAVITRON SELECT SPS G124 THEY ALLEGE THAT THEY HAVE NO WATER AND THE HANDPIECE AND HANDPIECE CABLE ARE GETTING HOT, NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20211736 ↗MalfunctionApr 1, 2024Overheating of Device; No Flow; Overheating of Device; No Flow
WHILE THE CUSTOMER WAS USING A CAVITRON 300 SERIES G310 THEY ALLEGE THAT THEY THINK CLOGGED LINES, AND SAID FOR A WHILE INSERTS WERE HEATING UP, NOW THEY HAVE NO CAVITATION. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19013074 ↗MalfunctionMar 12, 2024Restricted Flow rate; Overheating of Device; Restricted Flow rate; Overheating of Device
WHILE USING A CAVITRON 300 SERIES G310 THEY ALLEGE THAT THEY HAVE LOW WATER FLOW AND THE HANDPIECE HEATS UP; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18887182 ↗MalfunctionDec 4, 2023Overheating of Device; Overheating of Device
WHILE THE CUSTOMER WAS USING A CAVITRON 300 SERIES G310 THEY ALLEGE THAT THE UNIT GETS VERY HOT TO THE TOUCH AND THE CAVITRON TIP HAS BURNT. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18256854 ↗MalfunctionNov 16, 2023Restricted Flow rate; Overheating of Device; No Flow; Restricted Flow rate; Overheating of Device; No Flow
IN THIS EVENT IT IS REPORTED THAT CAVITRON 300 SERIES G310 HAD MINIMAL TO NO WATER FLOW AND WAS GETTING HOT. OUTCOME IS UNKNOWN AS OF THIS MDR.
Patient problems: Insufficient Information
MAUDE report 18150160 ↗
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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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