Data / Medical devices / Israel / Stratasys Ltd
Stratasys Ltd: FDA-registered device maker in Kiryat Gat Southern, Israel, 1 510(k) clearance
Stratasys Ltd is registered with the FDA (registration 3016074824) in Kiryat Gat Southern, Israel. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 7, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016074824
- Address
- 10 Habarzel st, Kiryat Gat Southern, Israel, 8258310
- Owner or operator
- Stratasys Ltd (10086646)
- Roles
- Manufacturer
- First device listed
- November 29, 2022
- Registered through
- 2026
- Brand names listed
- MED610, MED610-DSG, TrueDent Clear, TrueDent Cyan, TrueDent Magenta, TrueDent White, TrueDent Yellow
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 7, 2022 | K220771 | Stratasys TrueDent | EBI | Substantially Equivalent | Stratasys, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Additively Manufactured, Preformed, Resin Denture Tooth
- All makers of Material, Tooth Shade, Resin
- All makers of Resin, Denture, Relining, Repairing, Rebasing
Updated July 7, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.