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TrueDent TrueDent CyanRecalls & reported problems

Stratasys Ltd · Stratasys TrueDent™ is Stratasys TrueDent™ is a light-curable resin indicated for the fabrication of dental appliances including removable full and partial dentures, denture bases, denture teeth, bridges, crowns, inlays, onlays, and veneers in dental laboratories. The material is an alternative to traditional heat-curable and auto polymerizing resins. Stratasys TrueDent™ is intended exclusively for professional dental work. Fabrication of dental appliances with Stratasys TrueDent™ requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital dental files based on a digital impression, a Stratasys PolyJet 3D printer, and curing light equipment. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

4 other recalls cover devices cleared under the same FDA submission (K220771); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Jan 19, 2024Class IIICompleted

    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.

    Z-2091-2025 · Root cause: Software design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K220771. One submission often covers many models, so check the product and lot details in each record.

  • Z-2093-2025 · Jan 19, 2024 · Completed
    TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
  • Z-2090-2025 · Jan 19, 2024 · Completed
    TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
  • Z-2092-2025 · Jan 19, 2024 · Completed
    TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
  • Z-2094-2025 · Jan 19, 2024 · Completed
    TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances

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Sources and updates

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