Manufacturer registered with FDA
Athlos Oy
Espoo, Finland. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 5
- 510(k) clearances
- 12021–2021
- Markets registered in
- 32 registrations outside the US
- Establishments
- 1Finland
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Athlos Oy 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 | Athlos Oy | 1 clearances | 2021–2021 | Below |
| European Union | EUDAMED | Manufacturer | Athlos Oy | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Athlos Oy | 1 | — | 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 Athlos Oy currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| X-Ray Film HolderEGZ · Class 1 | — | Maker | Athlos-Air HoldersDC-Air Holders | 2021 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | Athlos-1Athlos-AirDC-Air | 2021 |
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 Athlos Oy as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 22 Jul 2021 | K211688 | DC-Air and Athlos-1 and Athlos-Air | MUH Digital Extraoral Source X-Ray System |
Some of these clearances are listed with FDA today by another company: Cefla S.C. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ATHLOS OYFDA reg. 3020117925 | Espoo Uusimaa, Finland | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10082517). 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.