FDA Product Code EBW: Controller, Foot, Handpiece And Cord
FDA product code EBW covers foot controllers, dental handpiece bodies, and cords used as accessories in dental procedures.
These components enable hands-free speed control of dental handpieces through foot pedal activation, allowing the clinician to adjust rotational speed without removing hands from the operative field. They are used with air-driven and electric dental handpiece systems.
EBW devices are Class I medical devices, regulated under 21 CFR 872.4200 and reviewed by the FDA Dental panel.
Leading manufacturers include Micro-Nx Co., Ltd., Nakanishi, Inc. and Saeshin Precision Co., Ltd..
FDA 510(k) Cleared Controller, Foot, Handpiece And Cord Devices (Product Code EBW)
About Product Code EBW - Regulatory Context
510(k) Submission Activity
61 total 510(k) submissions under product code EBW since 1977, with 61 receiving FDA clearance (average review time: 212 days).
Submission volume has remained relatively stable over the observed period, with 5 submissions in the last 24 months.
FDA 510(k) Review Time - EBW Product Code
Recent submissions under EBW have taken an average of 313 days to reach a decision - up from 203 days historically. Manufacturers should account for longer review timelines in current project planning.
EBW devices are reviewed by the Dental panel. Browse all Dental devices →