Lucitone Digital IPN 3D Premium Tooth 906384Recalls & reported problems
Dentsply Professional · 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 D0039063840), received between Apr 23, 2026 and Apr 23, 2026 — 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. 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
- 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.
MalfunctionApr 23, 2026Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A PATIENT EXPERIENCED ALLERGIC REACTION TO THE USE OF LUC DIGITAL IPN 3D PREMIUM TOOTH - 500ML - SHADE A3.5. PATIENT HAD A FOLLOW UP APPOINTMENT AND HAD COMPLAINT OF WHAT THOUGHT TO BE DENTURE STOMATITIS. PATIENT WAS TREATED WITH NYSTATIN AND ADVISED NOT WEAR THE DENTURE AT NIGHT. THE ERYTHEMA WAS NOT RESOLVED AND POSSIBLY DETERMINED THAT THE PATIENT EXPERIENCED AN ALLERGY TO SOMETHING IN THE ACRYLIC.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 24968347 ↗
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.
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