Manufacturer registered with FDA
Stratasys Ltd
Rehovot, Israel. Lists 5 dental device types with FDA across 2 registered establishments, and holds 1 510(k) clearance as applicant.
- Device types listed
- 5
- Brands and models
- 22
- 510(k) clearances
- 12022–2022
- Markets registered in
- 622 registrations outside the US
- Establishments
- 2Israel
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Stratasys Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Stratasys Ltd | 1 clearances | 2022–2022 | Below |
| South Korea | MFDS | Manufacturer | Stratasys Ltd. | 13 | 2012–2015 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Stratasys Ltd. | 3 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Stratasys Ltd. | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | STRATASYS LTD. | 2 | 2014–2019 | Pure Global AI |
| Australia | TGA | Manufacturer | Stratasys Ltd | 1 | 2026–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Stratasys Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | TrueDent ClearTrueDent CyanTrueDent MagentaTrueDent WhiteTrueDent Yellow | 2022 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | TrueDent ClearTrueDent CyanTrueDent MagentaTrueDent WhiteTrueDent Yellow | 2022 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | TrueDent ClearTrueDent CyanTrueDent MagentaTrueDent WhiteTrueDent Yellow | 2022 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | MED610MED610-DSG | 2023 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | TrueDent ClearTrueDent CyanTrueDent MagentaTrueDent WhiteTrueDent Yellow | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| STRATASYS LTDFDA reg. 3016074824 | Kiryat Gat Southern, Israel | Manufacturer |
| STRATASYS LTD - HeadquarterFDA reg. 3017374693 | Rehovot Central, Israel | Complaint file establishment, Specification developer |
Other names on FDA records
STRATASYS LTD - Headquarter
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086646). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.