NUPRO® Prophylaxis Paste with Fluoride 801232Recalls & reported problems
Dentsply International Inc. · NUPRO® Prophy Paste, Mint, Fine, Single Box (200 cups) · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D0038012321), received between Jan 20, 2025 and Jan 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).
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
- Patient-Device Incompatibility1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A PATIENT HAD AN REACTION TO THE FINE MINT W/F CUPS NUPRO AFTER A RECENT DENTAL CLEANING. NO INJURY WAS REPORTED AFTER THE ALLEGED EVENT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 21190400 ↗
Other AGENT, POLISHING, ABRASIVE, ORAL CAVITY devices
- Darby Dental Supply, LLC 9518637Darby Dental Supply, LLC · AGENT, POLISHING, ABRASIVE, ORAL CAVITY1 recall0 reports
- MI Paste Plus™ 422621Gc America Inc. · AGENT, POLISHING, ABRASIVE, ORAL CAVITY2 reports
- Enhance® Finishing System 624065Dentsply International Inc. · AGENT, POLISHING, ABRASIVE, ORAL CAVITY1 report
- Nupro® Prophy Paste with Fluoride 801120Dentsply International Inc. · AGENT, POLISHING, ABRASIVE, ORAL CAVITY1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.