Registered with FDA
SG Healthcare Co. Ltd
Moga-myeon, Icheon-si, South Korea. 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
- 43 registrations outside the US
- Establishments
- 1South Korea
Registered in 4 markets
Where regulators' registries name SG Healthcare Co. Ltd 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 | SG Healthcare Co. Ltd | 1 device types | — | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | sghealthcare Co Ltd | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | SG HealthCare Co., Ltd. | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SG HEALTHCARE CO., LTD. | 1 | 2025–2025 | 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 SG Healthcare Co. Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Lister | Hasla | 2025 |
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
SG Healthcare Co. Ltd 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: Yian Medical Technology (Haining) Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 9 Jan 2024 | K232710 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | OAS Dental Computed Tomography X-Ray |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SG HEALTHCARE CO LTDFDA reg. 3009715136 | Moga-myeon, Icheon-si Gyeonggi, South Korea | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10046997). 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.