MAUDE Adverse Event Report: DENTSPLY LLC LUC DT PRINT 3D O.OPQ RESIN PK; RESIN, DENTURE, RELINING, REPAIRING, REBASING

Catalog Number	906201
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While it is unknown if the device used in this case caused or contributed to the patient¿s symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.No material available for investigation.An allergic reaction is a known risk as detailed in 0060-risk-ra-0160 lines 1-2, and 5.The risk has been reduced as far as is possible, however it cannot be completely eliminated.
Event or Problem Description
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.

• Brand Name: LUC DT PRINT 3D O.OPQ RESIN PK
• Common Device Name: RESIN, DENTURE, RELINING, REPAIRING, REBASING
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 24607557
• Report Number: 2424472-2026-00606
• Device Sequence Number: 18538326
• Product Code: EBI
• UDI-Device Identifier: D0019062010
• UDI-Public: D0019062010
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K190043, K19
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 906201
• Device Lot Number: 00143500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/05/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown