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..
FDA 510(k) Cleared X-ray, Tomography, Computed, Dental Devices (Product Code OAS)
About Product Code OAS - Regulatory Context
510(k) Submission Activity
130 total 510(k) submissions under product code OAS since 2001, with 130 receiving FDA clearance (average review time: 138 days).
Submission volume has remained relatively stable over the observed period, with 14 submissions in the last 24 months.
FDA Review Time
FDA review times for OAS submissions have been consistent, averaging 144 days recently vs 137 days historically.
OAS devices are reviewed by the Radiology panel. Browse all Radiology devices →