Is this your brand? Sign in to claim ownership.
Sign in to claim this brandAIOBIO Co., Ltd.
US
Last updated May 23, 2026
What AIOBIO Co., Ltd. makes
AIOBIO Co., Ltd. manufactures reusable and disposable dental instruments, including adjustable mouth gags, fibreoptic dental lights, and intraoral cameras. Their portfolio also includes intraoral optical scanning systems and reflective dental room lights, designed for clinical use in dental procedures. The company produces specific models such as the Qraycam PRO and Qraypen, which are intended for intraoral imaging and scanning applications.
The company’s devices are regulated under FDA classifications, with products authorised as Class I and Class II medical devices. These devices are listed under the FDA’s 510(k) and Unique Device Identification (UDI) systems. AIOBIO Co., Ltd. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does AIOBIO Co., Ltd. manufacture?
AIOBIO Co., Ltd. specializes in dental devices, including reusable and disposable instruments. Their portfolio covers adjustable mouth gags, fibreoptic dental lights, intraoral cameras, intraoral optical scanning systems, and reflective dental room lights. These products are designed for clinical use in dental procedures, ensuring precision and efficiency during treatments.
Where is AIOBIO Co., Ltd. based?
AIOBIO Co., Ltd. is headquartered in the United States. The company’s location in the US aligns with its focus on manufacturing and distributing medical devices regulated under FDA standards.
Which regulatory registries list AIOBIO Co., Ltd.’s devices?
AIOBIO Co., Ltd.’s devices are listed under the FDA’s 510(k) premarket notification process and the Unique Device Identification (UDI) system. These registries ensure compliance with US medical device regulations and facilitate traceability and monitoring of their authorised products.
How are AIOBIO Co., Ltd.’s devices classified under FDA regulations?
AIOBIO Co., Ltd.’s devices are authorised as either Class I or Class II medical devices under FDA regulations. Class I devices generally pose minimal risk and require less stringent controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on the specific design and intended use of each device.
What are some examples of specific devices manufactured by AIOBIO Co., Ltd.?
AIOBIO Co., Ltd. produces several specific models, including the Qraycam PRO and Qraypen. The Qraycam PRO is designed for intraoral imaging, while the Qraypen is intended for intraoral optical scanning applications. These devices are part of their broader portfolio of dental instruments aimed at improving clinical workflows.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 694894136
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aiobio | Qraypen | FDA UDI | Class I | Active |
| Aiobio | LINKDENS VU | FDA UDI | Class I | Active |
| Aiobio | LINKDENS QC | FDA UDI | Class II | Active |
| Aiobio | Qscan Plus | FDA UDI | Class I | Active |
| Aiobio | W-Block | FDA UDI | Class I | Active |
| Aiobio | W-Block | FDA UDI | Class I | Active |
| Qraycam PRO | K221275 | FDA 510(k) | Class II | Active |
| Qraypen | K183121 | FDA 510(k) | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Aiobio Co., Ltd. Seongnam-si Gyeonggi · KR FEI 3014980444