FDA Registration
Active
🇺🇸 United States
Sagemax Paint 3D
Reg #: 2244842
·
FEI: 2244842
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Ivoclar Vivadent Manufacturing, Inc
- Registration Number
- 2244842
- FEI Number
- 2244842
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 500 MEMORIAL DR.
- City
- Somerset
- State
- NJ
- ZIP
- 08873
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151894
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2015-10-29 |
Proprietary Names
Sagemax Paint 3D
IPS e.max Ceram Art
IPS Ivocolor
IPS Ivocolor Intro Kit
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)