510(k) Report

FDA applicant

Stratasys, Ltd.

Rehovot, IL1 decision2022–20225 recalls

FDA records 1 decision for Stratasys, Ltd. (Rehovot, IL) in 2022: 1 510(k) clearance. All are in product code EBI (Resin, Denture, Relining, Repairing, Rebasing). Its devices cite 1 predicate, 0 of them its own earlier devices. 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Stratasys, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

5in 2024

2024: 5
2022high 5 (2024) · low 0 (2022)2026

Class I Class II/III not classified

FIG. 1 — Stratasys, Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EBIResin, Denture, Relining, Repairing, Rebasing1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K220771Stratasys TrueDentStratasys, Ltd. · 20221cites it

What has FDA decided for it lately?

  • K220771Stratasys TrueDentStratasys, Ltd. · 20225 recalls

The one decision as Stratasys, Ltd. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K220771TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that…Jan 19, 2024Class III
  • K220771TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that…Jan 19, 2024Class III
  • K220771TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that…Jan 19, 2024Class III
  • K220771TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that…Jan 19, 2024Class III
  • K220771TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin…Jan 19, 2024Class III