FDA Registration
Active
🇦🇹 Austria
IVOCLAR VIVADENT Manufacturing GmbH
Reg #: 1000493628
·
FEI: 1000493628
·
Expires 2026
Products
5
Proprietary Names
16
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- IVOCLAR VIVADENT Manufacturing GmbH
- Registration Number
- 1000493628
- FEI Number
- 1000493628
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- BREMSCHLSTRASSE 16
- City
- BURS Vorarlberg
- Country
- AT
Owner / Operator
- Firm Name
- IVOCLAR VIVADENT
- Operator Number
- 8010208
- Address
- 175 Pineview Dr.
- City
- Amherst
- State
- NY
- Postal Code
- 14228
- Country
- US
- Correspondent
- Dana Glina
US Agent
- Business Name
- Ivoclar Vivadent
- Contact Name
- Anderjeet Gulati
- Address
- 175 Pineview Dr.
- City
- Amherst
- State
- NY
- ZIP
- 14228
- Country
- US
- [email protected]
- Phone
- 716 2642046
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Amalgamator, Dental, Ac-Powered | EFD | Class 1 | Dental | No | 2004-01-15 |
| Ink, Arch Tracing | KZO | Class 1 | Dental | No | 2017-09-28 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2011-09-02 |
| Facebow | KCR | Class 1 | Dental | No | 2005-07-07 |
| Articulators | EJP | Class 1 | Dental | No | 2005-07-07 |
Proprietary Names
Silamat S6
Gnathometer- CAD
Gnathometer-M
Bluephase G4
Bluephase G4 100
Bluephase EasyCure
Universal Transferbow System (UTS) CAD
Candulor Registration Set
CRS-10
Bite Fork Set
Bite Fork
UNIVERSAL TRANSFERBOW
UNIVERSAL TRANSFERBOW SYSTEM (UTS)
Bluephase PowerCure
Articulator CA 3
STRATOS
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device