MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC THERMASEAL RIBBON STARTER KIT; RESIN, ROOT CANAL FILLING

Catalog Number	RIBBON
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hyperresponsive to stimuli (4538)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.Investigation: retain the consistency and the setting behavior of the material are okay and within specification.The material sets.The complaint is inconclusive.Dhr the dhr of the complained batch was checked.There were no abnormalities in the dhr.
Event or Problem Description
In this event it is reported that patient experienced due to the use of thermaseal ribbon starter kit.No injury occurred.

• Brand Name: THERMASEAL RIBBON STARTER KIT
• Common Device Name: RESIN, ROOT CANAL FILLING
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 24277570
• Report Number: 2320721-2026-00010
• Device Sequence Number: 8579847
• Product Code: KIF
• UDI-Device Identifier: D716RIBBON1
• UDI-Public: D716RIBBON1
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K960548
• 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): 02/06/2026

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?: No
• Device Catalogue Number: RIBBON
• Device Lot Number: 2412000067
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/28/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown