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 Nakanishi, Inc., W&H Dentalwerk Buermoos GmbH and Micro-Nx Co., Ltd..
61
Total
61
Cleared
212d
Avg days
1977
Since
61 devices
Cleared
Feb 28, 1997
MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN
Bell Intl., Inc.
Dental
86d
Cleared
Feb 27, 1991
MODIFIED SITE PERISTALTIC FOOTSWITCH
Site Microsurgical Systems, Inc.
Dental
75d
Cleared
May 14, 1979
OPTIONAL ACCESSORY FOOT SWITCH MODEL 100
Applied Medical Research
Dental
88d