Manufacturer registered with FDA
Smylio
Fremont, CA, United States. Lists 5 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 11
- 510(k) clearances
- 42018–2026
- Markets registered in
- 319 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Smylio 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 | Smylio | 4 clearances | 2018–2026 | Below |
| Canada | Health Canada | Registration holder | SMYLIO INCORPORATED | 17 | 2021–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Smylio Inc | 2 | — | 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 Smylio 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 | AirFlex AlignersFXBright AlignerFXClear AlignerNiTime AlignersPrecision Finish AlignerRescue Aligner | 2023 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | FXBright RetainersFXClear RetainersFXTetra Bright RetainersSmylio Retainer 1 | 2020 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | — | 2021 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | OrthoFX Tray | 2020 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | — | 2020 |
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 Smylio as the applicant.
Also lists devices cleared under other names
Smylio 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: Philips Medical Systems International BV (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 5 Aug 2005 | K052090 | SPLASH! IMPRESSION MATERIAL DEVICE | Philips Medical Systems International BV | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SMYLIOFDA reg. 3015143007 | Fremont, CA, United States | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058597). 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.