BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONTEMPLATE ALIGNER ARCH

    MDR report key: 23862720 · Received December 22, 2025

    Report

    Report Number
    1649995-2025-00079
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    December 19, 2025
    Report Date
    February 17, 2026
    Manufacturer
    DENTSPLY SIRONA ORTHODONTICS INC.
    Product Code
    NXC
    UDI-DI
    00856379007023
    PMA / PMN Number
    K171860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS; THIS IS A DIY ALIGNER. DIAGNOSTIC MODEL AND ALSO THE STAGING LOOKS GOOD FROM THE DIGITAL ASPECT. I DO NOT SEE ANY DEFECTS DIGITALLY. WE REVIEWED THE DHR FOR THIS (B)(4) / PATIENT ID# (B)(6) / SITE ID# 00128, QTY. (B)(4) ASSY-500011 (ALIGNERS) AND (B)(4) ASSY-500010 (TEMPLATE) WERE PACKAGED BY THE FIRST SHIFT BY AUTO BAG-AND-BOX OPERATION ON JULY 28, 2025, IN MANUFACTURING SUPERCELL SC4, EQUIPMENT PUA-09. THE SALES ORDER WAS INSPECTED AND MET THE ACCEPTANCE CRITERIA PROVIDED BY QA.

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A PATIENT USING NONTEMPLATE ALIGNER ARCH HAD ONE OF THEIR UPPER TEETH TO INTRUDE, UNINTENDED MOVEMENT OF THE TOOTH OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688018 NONTEMPLATE ALIGNER ARCH ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA ORTHODONTICS INC. 00856379007023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention