Manufacturer registered with FDA
Clearpath Orthodontics
Lahore, Pakistan. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 22017–2021
- Markets registered in
- 312 registrations outside the US
- Establishments
- 1Pakistan
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Clearpath Orthodontics 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 | Clearpath Orthodontics | 2 clearances | 2017–2021 | Below |
| Colombia | INVIMA | Manufacturer | CLEARPATH ORTHODONTICS | 7 | — | Pure Global AI |
| Australia | TGA | Manufacturer | ClearPath Orthodontics Pvt Ltd | 5 | 2012–2023 | 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 Clearpath Orthodontics 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 | Clearpath Aligner | 2016 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Defence Dental Center | 2022 |
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 Clearpath Orthodontics as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 5 Jan 2021 | K202857 | ClearPath Aligner | NXC Sequential Aligner |
| 6 Jul 2017 | K162609 | ClearPath Aligner | NXC Sequential Aligner |
Some of these clearances are listed with FDA today by another company: Ortho Organizers, Inc. (1).
Also lists devices cleared under other names
Clearpath Orthodontics lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Qserve America, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 1 Nov 2013 | K123514 | CLEARPATH ALIGNER | Qserve America, Inc. | NXC Sequential Aligner |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Clearpath OrthodonticsFDA reg. 3009157552 | Lahore Punjab, Pakistan | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10051683). 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.