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

Catalog Number	AHPBIOREFILL
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
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.Customer not returning and no lot number provided.Product not received at investigation site.
Event or Problem Description
In this event it was reported that the ahpbioseal showed resorption requiring retreatment.No patient injury.

• Brand Name: AH PLUS BIOCERAMIC SEALER REFILL SYRINGE
• 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: 22769599
• Report Number: 2320721-2025-00083
• Device Sequence Number: 9289092
• Product Code: KIF
• UDI-Device Identifier: D716AHPBIOREFILL1
• UDI-Public: D716AHPBIOREFILL1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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?: No
• Device Catalogue Number: AHPBIOREFILL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/06/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown