BEUDAMED
    FDA Enforcement Class III Completed

    TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    Recall: Z-2090-2025 · Reported July 16, 2025

    Enforcement

    Recall Number
    Z-2090-2025
    Event ID
    97021
    Classification
    Class III
    Status
    Completed
    Product Type
    Devices
    Firm
    STRATASYS LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 16, 2025
    Initiation Date
    January 19, 2024
    Classification Date
    July 7, 2025
    Address
    1, Holtzman St, N/A, Rehovot, N/A, N/A, Israel

    Description

    TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    Reason

    Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.

    Code Info

    UDI-DI 7290018915004 Lots 22994 (exp. 02-Apr-2024) and 23425 (exp. 07-Nov-2024)

    Distribution

    US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, Nebraska, New York, North Carolina, North Dakota, Oklahoma, Oregon, Utah, Wisconsin.

    Quantity

    78