MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC AH PLUS BIOCERAMIC SEALER STARTER KIT; RESIN, ROOT CANAL FILLING

Catalog Number	AHPBIOSEAL
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.Customer not returning.Product not received at investigation site.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Event or Problem Description
In this event it was reported that the ahpbioseal - ah plus bioceramic sealer starter kit - showed resorption requiring retreatment.

• Brand Name: AH PLUS BIOCERAMIC SEALER 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: 21172762
• Report Number: 2320721-2025-00041
• Device Sequence Number: 4538710
• Product Code: KIF
• UDI-Device Identifier: D716AHPBIOSEAL1
• UDI-Public: D716AHPBIOSEAL1
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/16/2025

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: AHPBIOSEAL
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/18/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown