FDA Registration
Active
🇩🇪 Germany
Pala Digital Denture Starter Kit
Reg #: 3005665377
·
FEI: 3005665377
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
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 |
|---|---|---|---|---|---|
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2021-01-21 |
Proprietary Names
Pala Digital Denture Starter Kit
Universal Silicone Adhesive
Pala Digital Impression Tray
Pala Digital Denture Tray Refill
Establishment Types
Export Device to the United States But Perform No Other Operation on Device