MAUDE Adverse Event Report: DENTSPLY LLC LUC DIGITAL IPN 3D PREMIUM TOOTH - 500ML - SHADE A3.5; ADDITIVELY MANUFACTURED, PREFORMED, RESIN DENTURE TOOTH

Catalog Number	906384
Medical Device Problem Code	Patient-Device Incompatibility (2682)
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.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
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.

• Brand Name: LUC DIGITAL IPN 3D PREMIUM TOOTH - 500ML - SHADE A3.5
• Common Device Name: ADDITIVELY MANUFACTURED, PREFORMED, RESIN DENTURE TOOTH
• 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: 24968347
• Report Number: 2424472-2026-00688
• Device Sequence Number: 16097289
• Product Code: PZY
• UDI-Device Identifier: D0039063840
• UDI-Public: D0039063840
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 05/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 906384
• Device Lot Number: 00170211
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/13/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown