BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AH PLUS BIOCERAMIC SEALER REFILL SYRINGE

    MDR report key: 22769612 · Received August 11, 2025

    Report

    Report Number
    2320721-2025-00085
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    August 6, 2025
    Report Date
    August 11, 2025
    Manufacturer
    TULSA DENTAL PRODUCTS LLC
    Product Code
    KIF
    UDI-DI
    D716AHPBIOREFILL1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IN THIS EVENT IT WAS REPORTED THAT THE AHPBIOSEAL SHOWED RESORPTION REQUIRING RETREATMENT. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160736 AH PLUS BIOCERAMIC SEALER REFILL SYRINGE RESIN, ROOT CANAL FILLING KIF TULSA DENTAL PRODUCTS LLC UNK D716AHPBIOREFILL1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention