BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONTEMPLATE ALIGNER ARCH

    MDR report key: 23463133 · Received November 4, 2025

    Report

    Report Number
    1649995-2025-00068
    Event Type
    Injury
    Date Received
    November 4, 2025
    Report Date
    December 30, 2025
    Manufacturer
    DENTSPLY SIRONA ORTHODONTICS INC.
    Product Code
    NXC
    UDI-DI
    00856379007023
    PMA / PMN Number
    K171860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE REVIEWED THE DHR FOR THIS (B)(6) / PATIENT ID# (B)(6) / SITE ID# (B)(4), QTY. (B)(4) ITEMS ASSY-500011 (ALIGNERS) AND 2 ITEMS ASSY-500010 (TEMPLATES) WERE PACKAGED BY THE SECOND SHIFT BY AUTO BAG AND BOX OPERATION ON (B)(6) 2025, MANUFACTURING SUPERCELL SC3, EQUIPMENT PUA-06. THE SALES ORDER WAS INSPECTED AND MET THE ACCEPTANCE CRITERIA PROVIDED BY QA. INCOMING INSPECTION. WE REVIEWED THE INCOMING INSPECTION RECORD FOR THE MATERIAL MANUFACTURING OF THIS (B)(6). · RAW MATERIAL: PART-501019 / LOT# 259386 / QTY. RECEIVED = 144 ROLLS, INSPECTION DATE: (B)(6) 2025. THE MATERIAL WAS FOUND TO BE ACCEPTABLE FOR USE IN THE MANUFACTURE OF THE SURE SMILE PRODUCT. FAILURE MODE - ALLERGIC REACTION. ROOT CAUSE - NO DEFECT. CONCLUSION CODE - NO FAILURE FOUND.

    Additional Manufacturer Narrative · 0

    WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT¿S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A PATIENT EXPERIENCED ALLERGIC REACTION DURING THE USE OF NONTEMPLATE ALIGNER ARCH ALIGNERS. PATIENT HAD RASH DUE TO THE ALIGNERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211997 NONTEMPLATE ALIGNER ARCH ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA ORTHODONTICS INC. 00856379007023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown