FDA Registration
Active
🇩🇪 Germany
Cara Scan 4i
Reg #: 3005665377
·
FEI: 3005665377
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- KULZER GMBH
- Registration Number
- 3005665377
- FEI Number
- 3005665377
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Leipziger StraBe 2
- City
- HANAU Hesse
- Country
- DE
Owner / Operator
- Firm Name
- KULZER, LLC
- Operator Number
- 9056636
- Address
- 4315 S. Lafayette Blvd.
- City
- South Bend
- State
- IN
- Postal Code
- 46614
- Country
- US
US Agent
- Business Name
- Kulzer, LLC
- Contact Name
- David Vincent
- Address
- 4315 S Lafayette Blvd
- City
- South Bend
- State
- IN
- ZIP
- 46614
- Country
- US
- [email protected]
- Phone
- 574 2995421
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2017-05-31 |
Proprietary Names
Cara Scan 4i
Cara Scan 4
Cara Scan 4 BUNDLE
Cara i500
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility