BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESMILE RETAINER

    MDR report key: 23484354 · Received November 6, 2025

    Report

    Report Number
    1649995-2025-00069
    Event Type
    Injury
    Date Received
    November 6, 2025
    Report Date
    December 30, 2025
    Manufacturer
    DENTSPLY SIRONA ORTHODONTICS INC.
    Product Code
    KMY
    UDI-DI
    00856379007269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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-500015 (RETAINERS) WERE PACKAGED BY THE FIRST SHIFT BY AUTO BAG AND BOX OPERATION ON OCTOBER 22, 2025, MANUFACTURING SUPERCELL SC3, EQUIPMENT PUA-05. 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 SO-(B)(6). · RAW MATERIAL: 1APL40C125-ORX / LOT# 10445159 / QTY. RECEIVED = (B)(4) PCS, INSPECTION DATE: SEPTEMBER 02, 2025. THE MATERIAL WAS FOUND TO BE ACCEPTABLE FOR USE IN THE MANUFACTURE OF THE SURE SMILE PRODUCT.

    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 AN ALLERGIC REACTION TO THE SURESMILE RETAINER. PATIENT REPORTED THEIR LIPS WERE SWOLLEN AFTER THEY STARTED WEARING THE RETAINERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2551099 SURESMILE RETAINER POSITIONER, TOOTH, PREFORMED KMY DENTSPLY SIRONA ORTHODONTICS INC. 00856379007269

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other