MAUDE Adverse Event Report: DENTSPLY DETREY GMBH AH PLUS EXPORT 3ML CHINA; RESIN, ROOT CANAL FILLING

Catalog Number	606.20.113
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr part 803.
Event or Problem Description
In this event it is reported that ah plus export 3ml china used in root canal treatment for pulpitis, the doctor tried the root canal filling material and the patient complained of continuous swelling and pain in the affected tooth.Doctor replace the root canal disinfectant that meet the standard concentration for root canal sealing.Immediate symptoms after intervention: mild relief of swelling and pain symptoms after intervention.
Additional Manufacturer Narrative
No lot, no returned product even after several requests -> for this no investigation on product level possible.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: AH PLUS EXPORT 3ML CHINA
• Common Device Name: RESIN, ROOT CANAL FILLING
• Manufacturer (Section D): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz baden-wurttemberg 78467 ; GM 78467
• Manufacturer (Section G): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz baden-wurttemberg 78467 ; GM 78467
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 23719551
• Report Number: 8010638-2025-00011
• Device Sequence Number: 20947408
• Product Code: KIF
• UDI-Device Identifier: D0106670031
• UDI-Public: D0106670031
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K243546
• 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): 01/12/2026

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: 606.20.113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/24/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown