Cavitron® 82005Recalls & reported problems
Dentsply Professional · FOCUSED SPRAY® slimLINE® FITGRIP® Ultrasonic Insert 30K FSI®-SLI®-10S FG · Class 2
Quick summary
This Dentsply Cavitron 82005 ultrasonic scaler insert is a thin dental tip that sprays water while scaling teeth. The 29 reports mostly describe the insert heating up and losing or restricting its water spray during use, with one report of the tip breaking off in tissue or plaque. There are 29 malfunctions, no deaths and no injuries. No recalls name 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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI D003820051), received between Mar 24, 2023 and Feb 17, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (23 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 Device23
- No Flow6
- Restricted Flow rate2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2026No Flow
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-10S INS, PKD ALLEGED HAS NO WATER FLOW. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24367437 ↗MalfunctionFeb 5, 2026No Flow
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-10S INS,PKD IS ALLEGED THAT NO WATER COMING OUT OF THE INSERT AND THIS IS OVERHEATING THE CAVITRON. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24267851 ↗MalfunctionJan 26, 2026Overheating of Device; No Flow
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-10S INS,PKD ALLEGEDLY OVERHEATED AND HAD NO WATER FLOW . NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24182853 ↗MalfunctionJan 22, 2026Overheating of Device; No Flow
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-10S INS,PKD IS ALLEGED THAT IT IS OVERHEATING AND NO WATER COMING OUT. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24145059 ↗MalfunctionDec 16, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-10S INS,PKD IS ALLEGED TO HAVE NO WATER FLOW AND WAS GETTING HOT. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824206 ↗MalfunctionJul 18, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-10S INS,PKD IS ALLEGED TO HEAT UP, NO WATER OR VIBRATION DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22540384 ↗MalfunctionJul 14, 2025Restricted Flow rate; Overheating of Device; Restricted Flow rate; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-10S INS, PKD ALLEGEDLY OVERHEATED DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22495690 ↗MalfunctionJul 7, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-10S INS,PKD ALLEGEDLY HEATED UP DURING USE. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22413305 ↗MalfunctionJun 19, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-10S INS, PKD INSERT ALLEGEDLY THE TIP OVERHEATS. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289406 ↗MalfunctionMay 12, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-FG-10S INS, PKD IS ALLEGED THE TIP IS HOT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22005214 ↗MalfunctionJan 20, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-10S INS, PKD ALLEGEDLY THE INSERT IS NOT VIBRATING AND HEATING UP. NO INJURY REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21190494 ↗MalfunctionJan 13, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-10S INS,PKD ALLEGEDLY THE INSERT HEATS UP TOO MUCH. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21137977 ↗MalfunctionSep 4, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-10S INS,PKD TIP BROKE AND PATIENT SWALLOWED THE BROKEN TIP. PATIENT WAS SENT TO EMERGENCY ROOM TO LOCATE TIP.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 20133988 ↗MalfunctionMay 20, 2024Restricted Flow rate; Overheating of Device; Restricted Flow rate; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-FG-10S INS,PKD INSERT GOT HOT DURING USE. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19355992 ↗MalfunctionMay 2, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-FG-10S INS,PKD INSERT GOT HOT DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19228418 ↗MalfunctionApr 12, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-FG-10S INS, PKD GOT HOT DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19094991 ↗MalfunctionJan 30, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-FG-10S INS,PKD ALLEGEDLY OVERHEATED DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18608092 ↗MalfunctionJan 22, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-FG-10S INS,PKD ALLEGEDLY OVERHEATED DURING USE AND BENT. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18554395 ↗MalfunctionJan 17, 2024Overheating of Device; No Flow; Overheating of Device; No Flow
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-FG-10S INS,PKD GOT HOT DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18531192 ↗MalfunctionNov 20, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-10S INS,PKD GOT HOT DURING USE. NO INJURY REPORTED IN THIS ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18170368 ↗MalfunctionJun 12, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-FG-10S INS,PKD GOT HOT DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17105555 ↗MalfunctionJun 12, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-10S INS,PKD OVERHEATED DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17105427 ↗MalfunctionMay 24, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-FG-10S INS,PKD IS ALLEGED TO GET WARM AND INSERT DOES NOT HOLD IN HANDPIECE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16991402 ↗MalfunctionMay 1, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-10S INS,PKD HAD NO WATER FLOW AND WAS GETTING HOT. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16844126 ↗MalfunctionApr 17, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-FG-10S INS, PKD OVERHEATED DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16750390 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.