Manufacturer registered with FDA
AIOBIO Co., Ltd.
Seoul, South Korea. Lists 4 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 7
- 510(k) clearances
- 22019–2024
- Markets registered in
- 37 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name AIOBIO 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 | Manufacturer | AIOBIO Co., Ltd. | 2 clearances | 2019–2024 | Below |
| Taiwan | TFDA | Manufacturer | AIOBIO CO., LTD.AIOBIO CO., LTD | 4 | 2019–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | AIOBIO Co Ltd | 3 | 2019–2025 | 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 AIOBIO 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 Operating LightEAZ · Class 1 | Dental operating lights | Maker | LINKDENS VUQrayview pro | 2024 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | MouthCAM ProQraypen, Qraypen C | 2022 |
| Light-Induced Fluorescence Caries DetectorNBL · Class 2 | Caries detection devices | Maker | LINKDENS QCQraycam PRO | 2024 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Outer Hood | 2025 |
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 |
|---|---|---|
| AIOBIO CO., LTD.FDA reg. 3014980444 | Seongnam-si Gyeonggi, South Korea | Complaint file establishment, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058846). 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.