FDA Registration
Active
🇮🇹 Italy
IPS Style Ceram
Reg #: 3003310824
·
FEI: 3003310824
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Ivoclar Vivadent Manufacturing GmbH
- Registration Number
- 3003310824
- FEI Number
- 3003310824
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via Gustav Flora 32
- City
- NATURNO (BZ) Bolzano
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K152103
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 |
|---|---|---|---|---|---|
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2016-05-24 |
Proprietary Names
IPS Style Ceram
IPS Style Ceram One
IPS Build-Up Liquid
IPS Style Ceram Transpa
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)