VATECH Co., Ltd. - FDA 510(k) Cleared Devices

VATECH Co., Ltd. is a leading manufacturer of radiographic imaging solutions for dental, medical, and veterinary applications. The company operates with a manufacturing facility in Sound Beach, US, and maintains a global presence across over 70 countries worldwide.

VATECH has established a strong FDA 510(k) regulatory record with 39 FDA 510(k) clearances from 39 total submissions. The company specializes exclusively in Radiology devices, with clearances spanning from 2008 to 2025. The latest clearance in 2025 demonstrates continued active development and market engagement.

VATECH's product portfolio encompasses advanced imaging technologies including 3D cone beam computed tomography (CBCT) systems, 2D panoramic and cephalometric devices, intraoral imaging systems, and integrated diagnostic software solutions. The company is recognized for pioneering innovations such as the world's first 3-in-1 digital X-ray system and carbon nanotube portable intraoral technology.

Explore the complete list of VATECH's FDA 510(k) cleared devices, including model numbers and clearance dates, to review the company's regulatory submissions and product history.

Regulatory submissions have been managed by Mtechgroup and Mtech Group, LLC.