FDA Registration
Active
🇨🇦 Canada
OptraGate for Scanning Assortment
Reg #: 3009496224
·
FEI: 3009496224
·
Expires 2025
Products
1
Proprietary Names
9
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
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 |
|---|---|---|---|---|---|
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2015-10-29 |
Proprietary Names
OptraGate for Scanning Assortment
OptraGate Test Pack
OpraGate Regular
OptraGate Small
OptraGate Assortment
OptraGate Junior Assortment Blue & Pink
OptraGate Small Assortment Blue & Pink
OptraGate Junior
OptraGate 2
Establishment Types
Export Device to the United States But Perform No Other Operation on Device