Palodent® Plus Sectional Matrix System 659760Recalls & reported problems
Dentsply International Inc. · Palodent Plus Universal Ring Refill · Class 1
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI D0026597601), received between Oct 20, 2023 and Jan 9, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break7
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PALODENT PLUS UNIV 2 RING BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24019328 ↗MalfunctionAug 27, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT PALODENT PLUS UNIV 2 RING REF RING BROKE DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22902035 ↗MalfunctionAug 15, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PALODENT PLUS UNIV 2 RING REF BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22817288 ↗MalfunctionApr 18, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT PALODENT PLUS UNIV 2 RING REF BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21864208 ↗MalfunctionNov 11, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT PALODENT PLUS UNIV 2 RING REF BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20659925 ↗MalfunctionNov 28, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT PALODENT PLUS UNIV 2 RING BROKE DURING USE. REPORTEDLY, NO MEDICAL INTERVENTION WAS REQUIRED, NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18216011 ↗MalfunctionOct 20, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT PALODENT PLUS UNIV 2 RING REF BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR.
Patient problems: Insufficient Information
MAUDE report 17974502 ↗
Other INSTRUMENTS, DENTAL HAND devices
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- Palodent® V3 Sectional Matrix System Designed by Triodent® 659760VDentsply International Inc. · INSTRUMENTS, DENTAL HAND27 reports
- AutoMate® 663016Dentsply International Inc. · INSTRUMENTS, DENTAL HAND25 reports
- Automatrix Snippers+ Catch Tray 62422605Dentsply De Trey GmbH · INSTRUMENTS, DENTAL HAND13 reports
- Palodent® V3 Sectional Matrix System Designed by Triodent® 659900VDentsply International Inc. · INSTRUMENTS, DENTAL HAND9 reports
- Palodent® V3 Sectional Matrix System Designed by Triodent® 659770VDentsply International Inc. · INSTRUMENTS, DENTAL HAND7 reports
- AutoMate® 663100Dentsply International Inc. · INSTRUMENTS, DENTAL HAND5 reports
- Palodent® V3 EZ Coat Sectional Matrix System Designed by Triodent® 659670VDentsply International Inc. · INSTRUMENTS, DENTAL HAND2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.