FDA Product Code EKX: Handpiece, Direct Drive, Ac-powered
Leading manufacturers include Perimetrics, Inc., SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. and Genoss Co., Ltd..
FDA 510(k) Cleared Handpiece, Direct Drive, Ac-powered Devices (Product Code EKX)
About Product Code EKX - Regulatory Context
510(k) Submission Activity
89 total 510(k) submissions under product code EKX since 1976, with 89 receiving FDA clearance (average review time: 183 days).
Submission volume has increased in recent years - 9 submissions in the last 24 months compared to 7 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under EKX have taken an average of 257 days to reach a decision - up from 175 days historically. Manufacturers should account for longer review timelines in current project planning.
EKX devices are reviewed by the Dental panel. Browse all Dental devices →