Cavitron® 80395Recalls & reported problems
Dentsply Professional · FOCUSED SPRAY® slimLINE® Ultrasonic Insert 30K FSI®-SLI®-10S · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply Cavitron 80395 ultrasonic scaler insert is a thin tip that sprays water while removing plaque. Most of the 36 reports describe the tip getting very hot during use, sometimes with little or no water coming through; one report mentions the tip breaking off. No deaths or injuries were reported. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI D003803951), received between Apr 6, 2023 and Feb 23, 2026 — classified as 36 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (33 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Overheating of Device33
- No Flow5
- Restricted Flow rate3
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2026Restricted Flow rate; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-10S INSERT,PKD IS ALLEGED TO NOT SPRAYING PROPERLY AND TIP GET REALLY HOT. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24415822 ↗MalfunctionDec 4, 2025Overheating of Device; No Flow; Overheating of Device; No Flow
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-10S INSERT,PKD ALLEGEDLY IS NOT SPRAYING WATER AND IS HEATING UP. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23716371 ↗MalfunctionSep 5, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-10S INSERT, PKD IS ALLEGED TO HAVE NO WATER COMING THROUGH, NO FLOW. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977348 ↗MalfunctionJul 28, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-10S INSERT,PKD ALLEGEDLY THE TIP HEATS UP AND NO WATER. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22639219 ↗MalfunctionApr 23, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-10S INSERT, PKD GOT HOT DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21890064 ↗MalfunctionApr 23, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-10S INSERT, PKD TIP BROKE DURING USE. IT IS UNSURE WHEN THE TIP BROKE, DOCTOR WAS CONCERNED THE PATIENT MAY HAVE SWALLOWED IT AND WAS SENT TO CHECK IF PATIENT DID SWALLOW BROKEN PART. FOUND THAT PATIENT DID NOT SWALLOW TIP. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21889949 ↗MalfunctionAug 13, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-10S INSERT,PKD ALLEGEDLY GOT HOT DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19974728 ↗MalfunctionJul 2, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-10S INSERT,PKD ALLEGEDLY GOT HOT. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19655928 ↗MalfunctionJun 24, 2024Overheating of Device; Overheating of Device
IN THIS CASE IT IS REPORTED THAT WHILE A 30K FSI-SLI-10S INSERT,PKD WAS BEING USED IT ALLEGEDLY GOT HOT. REPORTEDLY THE INSERT DOES NOT ALLOW WATER TO FLOW OUT OF THE TIP. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19601094 ↗MalfunctionJun 18, 2024Restricted Flow rate; Overheating of Device; Restricted Flow rate; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-10S INSERT,PKD IS ALLEGED TO GET HOT. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19556482 ↗MalfunctionJun 18, 2024Overheating of Device; No Flow; Overheating of Device; No Flow
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-10S INSERT,PKD ALLEGEDLY NO WATER IS COMING OUT OF THE INSERT AND IT WAS GETTING HOT. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19555977 ↗MalfunctionJun 14, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-10S INSERT GOT HOT DURING USE. REPORTEDLY NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19538462 ↗MalfunctionJun 6, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-10S INSERT,PKD TIP GOT HOT DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19475670 ↗MalfunctionMay 22, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-10S INSERT,PKD GOT HOT DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19369478 ↗MalfunctionMay 3, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-10S INSERT,PKD GOT HOT DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19237428 ↗MalfunctionFeb 7, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-10S INSERT, PKD GOT HOT DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18659266 ↗MalfunctionJan 17, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-10S INSERT,PKD GOT HOT DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18531463 ↗MalfunctionDec 19, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-10S INSERT,PKD THE INSERT GET HOT AND HAS IRREGULAR WATER FLOW DURING USE. NO INJURY OCCURRED FROM THIS ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18354493 ↗MalfunctionDec 15, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-10S INSERT,PKD IS ALLEGED TO HEAT UP AND GET HOT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18335283 ↗MalfunctionDec 11, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-10S INSERT,PKD INSERT HEATS UP AND GET HOT. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18302673 ↗MalfunctionNov 28, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-10S INSERT,PKD GETS EXTREMELY HOT DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18216565 ↗MalfunctionNov 14, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-10S INSERT,PKD GETS HOT DURING USE. NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18133037 ↗MalfunctionNov 8, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-10S INSERT, PKD GOT EXCESSIVELY HOT DURING USE. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18091319 ↗MalfunctionOct 24, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-10S INSERT,PKD GOT HOT DURING USE. NO INJURY FROM ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17994267 ↗MalfunctionOct 19, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-10S INSERT,PKD GOT HOT DURING USE. NO INJURY FOR THIS ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17964063 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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