FDA Registration
Active
🇺🇸 United States
uLab Systems, Inc
Reg #: 3017155477
·
FEI: 3017155477
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- uLab Systems, Inc
- Registration Number
- 3017155477
- FEI Number
- 3017155477
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7005 Appling Farms Parkway
- City
- Memphis
- State
- TN
- ZIP
- 38133
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192596
Owner / Operator
- Firm Name
- uLab Systems, Inc.
- Operator Number
- 10056850
- Address
- 7005 Appling Farms Parkway
- City
- Memphis
- State
- TN
- Postal Code
- 38133
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2020-07-15 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 2025-12-30 |
| Orthodontic Software | PNN | Class 2 | Dental | No | 2018-01-22 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2018-01-22 |
Proprietary Names
uLab Systems Dental Aligner
ULab Systems UDesign
uLab Systesm uDesign IDB
Establishment Types
Manufacture Medical Device