BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMILESET

    MDR report key: 25243177 · Received May 21, 2026

    Report

    Report Number
    3032193293-2026-00002
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 21, 2026
    Manufacturer
    ORTHO DENTAL LAB, LLC
    Product Code
    NXC
    PMA / PMN Number
    K212496
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE SMILESET ALL-DAY ALIGNERS CAUSED OR CONTRIBUTED TO THE PATIENTS SYMPTOMS. THIS EVENT IS BEING FILED AS A MDR AS THE PATIENT REPORTED A CRACKED TOOTH WHILE A SMILESET ALL-DAY ALIGNER WAS BEING USED.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED THAT THE LOWER ALIGNERS WERE TOO TIGHT AND CAUSED A TOOTH TO CRACK. THE CUSTOMER STATED THE TOOTH COULD NOT BE SAVED AND IT NEEDED TO BE EXTRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106110 SMILESET SMILESET ALL-DAY ALIGNERS NXC ORTHO DENTAL LAB, LLC 121-0106

    Patients

    Seq Age Sex Outcome Treatment
    1