STRATASYS LTD

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2091-2025Class IIITrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabJanuary 19, 2024
Z-2094-2025Class IIITrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabJanuary 19, 2024
Z-2090-2025Class IIITrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables faJanuary 19, 2024
Z-2092-2025Class IIITrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fJanuary 19, 2024
Z-2093-2025Class IIITrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables faJanuary 19, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K220771Stratasys TrueDentJuly 7, 2022