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 Cefla S.C., Nakanishi, Inc. and Micro-Nx 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 increased in recent years - 7 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under EBW have taken an average of 300 days to reach a decision - up from 201 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 →