Manufacturer registered with FDA
Atria Co.
Seoul, South Korea. Lists 14 dental device types with FDA across 1 registered establishment.
- Device types listed
- 14
- Brands and models
- 14
- 510(k) clearances
- 0as applicant
- Markets registered in
- 410 registrations outside the US
- Establishments
- 1South Korea
Registered in 4 markets
Where regulators' registries name Atria Co. 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 | Atria Co. | 14 device types | — | Below |
| Taiwan | TFDA | Manufacturer | ATRIA CO.ATRIA INC. | 8 | 2012–2022 | Pure Global AI |
| China | NMPA | Registration holder | 爱特利牙公司Atria Co. | 1 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Atria Co. | 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 Atria Co. currently lists, by FDA device type, with the brand and model names on the listing.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ATRIA Co.FDA reg. 3010896988 | Seoul, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10046598). 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.