BEUDAMED
    FDA Enforcement Class II Ongoing

    Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.

    Recall: Z-0315-2026 · Reported November 12, 2025

    Enforcement

    Recall Number
    Z-0315-2026
    Event ID
    97869
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    OSSTEM Implant Co., Ltd.
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    N/A
    Report Date
    November 12, 2025
    Initiation Date
    August 26, 2025
    Classification Date
    November 5, 2025
    Address
    66-16 Bansong-Ro 513beon-Gil, Busan City, Haeundae District, N/A, N/A, Korea (the Republic of)

    Description

    Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.

    Reason

    Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.

    Code Info

    UDI Codes: 08800000996059 and 08800000996042.

    Distribution

    U.S.

    Quantity

    N/A