510(k) K220771 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
Stratasys TrueDent
| Applicant | Stratasys, Ltd., Rehovot, IL |
| Decision | Substantially Equivalent, Jul 7, 2022 |
| Received | Mar 16, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220771
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2025 | STRATASYS LTD TrueDent Clear, TDM 100, Model No. OBJ-09164
Light-curable methacrylate-based resin that enables fabrication of dental appliances Completed |
EBI | None listed |
| Jul 7, 2025 | STRATASYS LTD TrueDent Cyan, TDM 120, Model No. OBJ-09165
Light-curable methacrylate-based resin that enables fabrication of dental appliances Completed |
EBI | None listed |
| Jul 7, 2025 | STRATASYS LTD TrueDent Magenta, TDM130, Model No. OBJ-09166
Light-curable methacrylate-based resin that enables fabrication of dental appliances Completed |
EBI | None listed |
| Jul 7, 2025 | STRATASYS LTD TrueDent Yellow, TDM140, Model No. OBJ-09169
Light-curable methacrylate-based resin that enables fabrication of dental appliances Completed |
EBI | None listed |
| Jul 7, 2025 | STRATASYS LTD TrueDent White, TDM110, Model No. OBJ-09168
Light-curable methacrylate-based resin that enables fabrication of dental appliances Completed |
EBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.