Lucitone Digital Print™ 3D Denture Resin - Original OpaqueRecalls & reported problems
Dentsply International Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 D0019062010), received between Mar 16, 2026 and Mar 16, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper Chemical Reaction” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Improper Chemical Reaction1
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.
MalfunctionMar 16, 2026Improper Chemical Reaction
WHILE THE CUSTOMER WAS USING A LUC DT PRINT 3D O.OPQ RESIN PK, THEY ALLEGE THAT A DENTURE WAS FITTED FOR A PATIENT IN SEPTEMBER AND WHEN THEY WERE SEEN FOR A REVIEW APT IN DECEMBER IT WAS THOUGHT THE PATIENT HAD DENTURE STOMATITIS. THEY WERE TREATED WITH NYSTATIN AND ADVISED THE PATIENT NOT TO WEAR AT NIGHT BUT THE ERYTHEMA HAS NOT RESOLVED. DOCTOR THOUGHT PATIENT HAD ALLERGIC REACTION TO THE ACRYLIC. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 24607557 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 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