FDA Registration
Active
🇨🇦 Canada
IPS e.max Ceram Glaze Spray
Reg #: 3009496224
·
FEI: 3009496224
·
Expires 2025
Products
1
Proprietary Names
10
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
- K012174
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 | 2007-11-14 |
Proprietary Names
IPS e.max Ceram Glaze Spray
IPS e.max Ceram Selection
IPS e.max Ceram
IPS Empress Staining
IPS e.max Ceram Power
IPS e.max CAD Crystall Shades
IPS e.max CAD Crystall Stains
IPS e.max CAD Crystall Glaze Spray
IPS e.max CAD Crystall Glaze Paste
IPS e.max Ceram Intro Kit
Establishment Types
Export Device to the United States But Perform No Other Operation on Device