FDA Registration
Active
🇮🇱 Israel
STRATASYS LTD
Reg #: 3016074824
·
FEI: 3016074824
·
Expires 2026
Products
5
Proprietary Names
7
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- STRATASYS LTD
- Registration Number
- 3016074824
- FEI Number
- 3016074824
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10 Habarzel st
- City
- Kiryat Gat Southern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K220771
Owner / Operator
- Firm Name
- Stratasys Ltd
- Operator Number
- 10086646
- Address
- 1 Holtzman street
- City
- Rehovot
- State
- Central
- Postal Code
- 7670401
- Country
- IL
- Correspondent
- Dafna Fitoussi
US Agent
- Business Name
- Stratasys Inc.
- Contact Name
- Michelle Ford
- Address
- 5995 Opus Pkwy
- City
- Minnetonka
- State
- MN
- ZIP
- 55343
- Country
- US
- [email protected]
- Phone
- 704 6185948
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | Class 2 | Dental | No | 2022-11-29 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2022-11-29 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2022-11-29 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2022-11-29 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2023-12-14 |
Proprietary Names
TrueDent Magenta
TrueDent Clear
TrueDent White
TrueDent Yellow
TrueDent Cyan
MED610-DSG
MED610
Establishment Types
Manufacture Medical Device