Stratasys TrueDent— 510(k) K220771
Substantially EquivalentStratasys, Ltd.
FDA 510(k) clearance K220771 for Stratasys TrueDent, Substantially Equivalent on 2022-07-07. Applicant: Stratasys, Ltd.. Device class: 2.
Clearance details
- Applicant
- Stratasys, Ltd.
- Product code
- Code EBI
- Device class
- Class 2
- Regulation
- 21 CFR 872.3760
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rehovot, IL
Recent devices under product code EBI
view allAdverse events under product code EBI
product code EBI- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K220771
K-number listed on FDA's recall record- Z-2090-2025 — TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Z-2091-2025 — TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Z-2092-2025 — TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Z-2093-2025 — TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Z-2094-2025 — TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K220771.
Data sourced from openFDA. This site is unofficial and independent of the FDA.