Nupro® Prophy Paste with Fluoride 801120Recalls & reported problems
Dentsply International Inc. · Nupro® Prophy Paste with Fluoride - Orange, Medium (Jar) · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D0038011201), received between Jun 7, 2023 and Jun 7, 2023 — classified as 1 injury.
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.
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.
InjuryJun 7, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT WHILE A CUSTOMER WAS USING MED ORANGE W/O JAR NUPRO, THEY ALLEGE THAT A PATIENT EXPERIENCED A ALLERGIC REACTION - PINS AND NEEDLES FEELING AND SLIGHTLY SWOLLEN FACE. REPORTEDLY, NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 17078023 ↗
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® Prophylaxis Paste with Fluoride 801232Dentsply International Inc. · AGENT, POLISHING, ABRASIVE, ORAL CAVITY1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page