FDA Registration
Active
🇺🇸 United States
UltraTemp
Reg #: 1718912
·
FEI: 1718912
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Ultradent Products Inc. / OraTech LLC
- Registration Number
- 1718912
- FEI Number
- 1718912
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 505 W Ultradent Dr (10200 South)
- City
- South Jordan
- State
- UT
- ZIP
- 84095
- Country
- US
Regulatory Submissions
- 510(k) Number
- K994261
Owner / Operator
- Firm Name
- ULTRADENT PRODUCTS, INC.
- Operator Number
- 1718962
- Address
- 505 West Ultradent Drive (10200 South), --
- City
- South Jordan
- State
- UT
- Postal Code
- 84095
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cement, Dental | EMA | Class 2 | Dental | No | 2007-12-20 |
Proprietary Names
UltraTemp
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device