FDA Product Code OAS: X-ray, Tomography, Computed, Dental

Under FDA product code OAS, dental computed tomography systems are cleared for three-dimensional imaging of the oral and maxillofacial region.

Also known as cone beam CT (CBCT) systems, these devices produce high-resolution 3D images of teeth, bone, and surrounding structures at a lower radiation dose than conventional medical CT. They are used in implant planning, orthodontic assessment, endodontics, and oral surgery.

OAS devices are Class II medical devices, regulated under 21 CFR 892.1750 and reviewed by the FDA Radiology panel.

Leading manufacturers include Ray Co., Ltd., VATECH Co., Ltd. and Cefla S.C..