Registered with FDA
Smileie,Inc.
Brookfield, WI, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 23 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Smileie,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 | Lister | Smileie,Inc. | 1 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Smileie Limited | 3 | — | 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 Smileie,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 | Lister | Smileie | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Smileie,Inc. 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: ClearMoves Aligners (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 1 Aug 2024 | K241137 | Clear Moves Aligner | ClearMoves Aligners | NXC Sequential Aligner |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SMILEIE,INC.FDA reg. 3032452779 | Brookfield, WI, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10096175). 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.