Manufacturer registered with FDA
uLab Systems, Inc.
Memphis, TN, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 42018–2022
- Markets registered in
- 35 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name uLab Systems, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | uLab Systems, Inc. | 4 clearances | 2018–2022 | Below |
| Australia | TGA | Manufacturer | uLab Systems Inc | 3 | 2022–2025 | Pure Global AI |
| Canada | Health Canada | Registration holder | ULAB SYSTEMS, INC. | 2 | 2021–2021 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What uLab Systems, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | uLab Systems Dental Aligner | 2020 |
| Orthodontic SoftwarePNN · Class 2 | Dental design & orthodontic software | Maker | ULab Systems UDesignuLab Systesm uDesign IDB | 2018 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | — | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names uLab Systems, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 24 Feb 2022 | K211510 | uLab Systems Dental Aligner Kit | NXC Sequential Aligner |
| 23 Jun 2020 | K200772 | ULab Systems uDesign Software | PNN Orthodontic Software |
| 11 Feb 2020 | K192596 | ULab Systems Dental Aligner Kit | NXC Sequential Aligner |
| 9 Jan 2018 | K171295 | ULab Systems Treatment Planning Software | PNN Orthodontic Software |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| uLab Systems, IncFDA reg. 3017155477 | Memphis, TN, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10056850). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.