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	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr 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 after use of ah plus bioceramic sealer some patients returned with no sealer, no fill or had short fills.Patient required retreatment.
Additional Manufacturer Narrative
The issue of resorption has been previously investigated and resulted in pre hhe-0237 and rat-000130.Investigation and discussions with the vendor have indicated the material is radiographically resorbed during the healing process.Root cause is unknown.As per hhe pre-assessment, no capa needed.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

• 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: 24321333
• Report Number: 2320721-2026-00011
• Device Sequence Number: 10049713
• Product Code: KIF
• UDI-Device Identifier: D716AHPBIOSEAL1
• UDI-Public: D716AHPBIOSEAL1
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 03/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: AHPBIOSEAL
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/08/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown