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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:214308

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

Official recall number

Z-2090-2025

Evidence summary

Product code
EBI
Recall status
Completed
Event initiated
January 19, 2024
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2090-2025

Field note

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