TrueDent TrueDent ClearRecalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07290018915004), received between Mar 19, 2025 and Mar 19, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Expiration Date Error” (4 reports).
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.
Reports received per month
Recalls naming this device
- 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-2090-2025 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Expiration Date Error4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2025Expiration Date Error; Expiration Date Error
THE CARTRIDGE IS NOT RECOGNISED BY THE PRINTER (RFID).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21648948 ↗MalfunctionMar 19, 2025Expiration Date Error; Expiration Date Error
THE CATRIDGE IS NOT RECOGNISED BY THE PRINTER (RFID).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21647916 ↗MalfunctionMar 19, 2025Expiration Date Error; Expiration Date Error
THE CATRIDGE IS NOT RECOGNISED BY THE PRINTER (RFID).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21644695 ↗MalfunctionMar 19, 2025Expiration Date Error; Expiration Date Error
THE CARTRIDGE IS NOT RECOGNISED BY THE PRINTER (RFID).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21644414 ↗
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-2091-2025 · Jan 19, 2024 · CompletedTrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Z-2093-2025 · Jan 19, 2024 · CompletedTrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Z-2092-2025 · Jan 19, 2024 · CompletedTrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Z-2094-2025 · Jan 19, 2024 · CompletedTrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Other Resin, Denture, Relining, Repairing, Rebasing devices
- TrueDent TrueDent YellowStratasys Ltd · Resin, Denture, Relining, Repairing, Rebasing1 recall13 reports
- TrueDent TrueDent MagentaStratasys Ltd · Resin, Denture, Relining, Repairing, Rebasing1 recall2 reports
- TrueDent TrueDent WhiteStratasys Ltd · Resin, Denture, Relining, Repairing, Rebasing1 recall0 reports
- TrueDent TrueDent CyanStratasys Ltd · Resin, Denture, Relining, Repairing, Rebasing1 recall0 reports
- Lynal® Tissue Conditioner and Temporary Reliner 653006Dentsply International Inc. · RESIN, DENTURE, RELINING, REPAIRING, REBASING3 reports
- COE-SOFT™ 344011Gc America Inc. · RESIN, DENTURE, RELINING, REPAIRING, REBASING2 reports
- Palapress Vario 64707889Kulzer GmbH · RESIN, DENTURE, RELINING, REPAIRING, REBASING1 report
- Mizzy Millennium 6010049Keystone Industries · RESIN, DENTURE, RELINING, REPAIRING, REBASING1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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