Data / Medical devices / United States / uLab Systems, Inc
uLab Systems, Inc: FDA-registered device maker in Memphis, TN, United States, 4 510(k) clearances
uLab Systems, Inc is registered with the FDA (registration 3017155477) in Memphis, TN, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 24, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017155477
- Address
- 7005 Appling Farms Parkway, Memphis, TN, United States, 38133
- Owner or operator
- uLab Systems, Inc. (10056850)
- Roles
- Manufacturer
- First device listed
- January 22, 2018
- Registered through
- 2026
- Brand names listed
- ULab Systems UDesign, uLab Systems Dental Aligner, uLab Systesm uDesign IDB
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Bracket, Orthodontic | ECQ | 1 | Manufacturer | accessdata.fda.gov |
| Aligner, Sequential | NXC | 2 | Manufacturer | accessdata.fda.gov |
| Orthodontic Software | PNN | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 24, 2022 | K211510 | uLab Systems Dental Aligner Kit | NXC | Substantially Equivalent | Ulab Systems, Inc. | accessdata.fda.gov |
| June 23, 2020 | K200772 | ULab Systems uDesign Software | PNN | Substantially Equivalent | Ulab Systems, Inc. | accessdata.fda.gov |
| February 11, 2020 | K192596 | ULab Systems Dental Aligner Kit | NXC | Substantially Equivalent | Ulab Systems, Inc. | accessdata.fda.gov |
| January 9, 2018 | K171295 | ULab Systems Treatment Planning Software | PNN | Substantially Equivalent | Ulab Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthodontic Software
- All makers of System, Image Processing, Radiological
- All makers of Aligner, Bracket, Orthodontic
- All makers of Aligner, Sequential
Updated February 24, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.