Chrysalis Intelligence · Sponsors · Stratasys, Ltd.

Stratasys, Ltd.

Rehovot, IL · 1 510(k) clearances · 5 recalls

Total clearances
1
2022-07-07 → 2022-07-07
Last 12 months
0
Product codes
1
Most recent
2022-07-07
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
EBI 1 2022-07-07
Safety

Recalls (5)

Class I (serious)
0
Risk of injury / death
Total recalls
5
Currently ongoing
0
Most recent
2024-01-19
DateSeverityStatusRecall # ProductCodeReason
2024-01-19 Class III Completed Z-2094-2025 TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental a… 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…
2024-01-19 Class III Completed Z-2093-2025 TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental … 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…
2024-01-19 Class III Completed Z-2092-2025 TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental… 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…
2024-01-19 Class III Completed Z-2091-2025 TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental a… 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…
2024-01-19 Class III Completed Z-2090-2025 TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental … 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…
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2022-07-07 K220771 Stratasys TrueDent EBI