Data / Medical devices / South Korea / Aiobio Co., Ltd.
Aiobio Co., Ltd.: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 2 510(k) clearances
Aiobio Co., Ltd. is registered with the FDA (registration 3014980444) in Seongnam-si Gyeonggi, South Korea. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014980444
- Address
- # 306 Sunil Technopia, 555 Dunchon-daero, Jungwon-gu, Seongnam-si Gyeonggi, South Korea, 13215
- Owner or operator
- AIOBIO Co., Ltd. (10058846)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- November 1, 2018
- Registered through
- 2026
- Brand names listed
- GAG, mouth, LINK DENS CLINIC, LINKDENS QC, LINKDENS VIEWER, LINKDENS VU, MouthCAM Pro, Outer Hood, Qraycam PRO and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gag, Mouth | KBN | 1 | Manufacturer | accessdata.fda.gov |
| Light, Examination, Medical, Battery Powered | KYT | 1 | Manufacturer | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Light-Induced Fluorescence Caries Detector | NBL | 2 | Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 4, 2024 | K221275 | Qraycam PRO | NBL | Substantially Equivalent | AIOBIO Co., Ltd. | accessdata.fda.gov |
| July 18, 2019 | K183121 | Qraypen | EIA | Substantially Equivalent | AIOBIO Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Light, Operating, Dental
- All makers of Unit, Operative Dental, Accessories
- All makers of Unit, Operative Dental
- All makers of Light-Induced Fluorescence Caries Detector
- All makers of Light, Examination, Medical, Battery Powered
- All makers of System, Digital Image Communications, Radiological
Updated September 4, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.