MAUDE Adverse Event Report: DENTSPLY INDUSTRIA E COMERCIO LTDA JELTRATE REG DUSTLESS 410 GR; MATERIAL, IMPRESSION

Catalog Number	05130150000
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event it is reported that students from a school of dentistry claim to have had an allergic reaction to the jeltrate reg dustless 410 gr.Reportedly, their symptoms included small blisters in the mouth, cheek and burning after being used in a practical procedure in class.
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.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the investigation results.The material has been duly tested and is in compliance with the established standards.The dhr of the material is evaluated, which shows that the material was produced and released in compliance.

• Brand Name: JELTRATE REG DUSTLESS 410 GR
• Common Device Name: MATERIAL, IMPRESSION
• Manufacturer (Section D): DENTSPLY INDUSTRIA E COMERCIO LTDA; rua jose francisco de souza 19; pirassununga sao paulo 13633 -412; BR 13633-412
• Manufacturer (Section G): DENTSPLY INDUSTRIA E COMERCIO LTDA; rua jose francisco de souza 19; pirassununga sao paulo 13633 -412; BR 13633-412
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 22202229
• Report Number: 8040288-2025-00007
• Device Sequence Number: 6887231
• Product Code: ELW
• UDI-Device Identifier: D0026052241
• UDI-Public: D0026052241
• Combination Product (Y/N): N
• 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): 09/03/2025

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: 05130150000
• Device Lot Number: ILEGIVEL NA EMBALAGEM
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/29/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown