Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014980444

FEI Number

3014980444

Entity Name

AIOBIO CO., LTD.

City/State/Country

Seongnam-si Gyeonggi, KR

Establishment Address

# 306 Sunil Technopia, 555 Dunchon-daero, Jungwon-gu, Seongnam-si Gyeonggi 13215, KR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

AIOBIO Co., Ltd. (Owner Number: 10058846)

Owner / Operator Contact Address

#801, 38, Teheran-ro 4-gil, Gangnam-gu, Seoul, KR-11 06241, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GAG, mouth W block LINKDENS QC Qraycam PRO LINKDENS VU Qrayview pro Qraypen, Qraypen C MouthCAM Pro Outer Hood Qscan Plus battery-powered medical examination light LINK DENS CLINIC LINKDENS VIEWER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2018-11-01
NBL	Laser, Fluorescence Caries Detection	Dental	Class 2	872.1745	2024-11-14
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2024-03-08
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2022-09-08
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2025-12-16
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2024-10-30
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2025-03-06

Official Correspondent

Casey Lee

US Agent Details

Dave Kim Business: Mtech Group LLC Email: davekim@mtechgroupllc.com Phone: (713) 4672607

Related Public Records

Same Entity

AIOBIO Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014980444. Last updated year: 2026. Please use registration number 3014980444 when referencing this establishment in official correspondence.