Cavitron® 82006Recalls & reported problems
Dentsply Professional · FOCUSED SPRAY® slimLINE® FITGRIP® Ultrasonic Insert 30K FSI®-SLI®-10L FG · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI D003820061), received between Aug 15, 2023 and Nov 2, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (2 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 Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 2, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-FG-10L INS,PKD GOT HOT DURING USE. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18059365 ↗MalfunctionAug 15, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-FG-10L INS, PKD GOT HOT DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17548043 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.