FDA Registration
Active
🇨🇦 Canada
IPS e.max ZirCAD MT Multi blocks
Reg #: 3009496224
·
FEI: 3009496224
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- IVOCLAR VIVADENT, INC.
- Registration Number
- 3009496224
- FEI Number
- 3009496224
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1-6600 Dixie Road
- City
- Mississauga Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K152118
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 | 2015-12-17 |
Proprietary Names
IPS e.max ZirCAD MT Multi blocks
IPS e.max ZirCAD MT discs
IPS e.max ZirCAD Prime Esthetic
Establishment Types
Export Device to the United States But Perform No Other Operation on Device