Class 3 Device Recall TrueDent

• Date Initiated by Firm: January 19, 2024
• Date Posted: July 07, 2025
• Recall Status: Completed
• Recall Number: Z-2094-2025
• Recall Event ID: 97021
• 510(K)Number: K220771
• Product Classification: Resin, denture, relining, repairing, rebasing - Product Code EBI
• Product: TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
• Code Information: UDI-DI 7290018915202 Lot 22377 (exp. 12-Oct-2023)
• Recalling Firm/ Manufacturer: STRATASYS LTD; 1, Holtzman St; Rehovot Israel
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Software design
• Action: The firm initiated the recall to the consignee level on January 15, 2024. Customers were asked to coordinate a cartridge replacement. The reporting of this recall was done by the firm retroactively; the issue was resolved in January 2024.
• Quantity in Commerce: 109
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.

• 510(K) Database: 510(K)s with Product Code = EBI