FDA Product Code EFB: Handpiece, Air-powered, Dental
FDA product code EFB covers air-powered dental handpieces used for cutting, drilling, and polishing in dental procedures.
These high-speed instruments use compressed air to rotate dental burs and attachments at speeds up to 400,000 RPM for efficient tooth preparation, cavity removal, and crown and bridge preparation. They are the most widely used dental instrument in clinical practice.
EFB devices are Class I medical devices, regulated under 21 CFR 872.4200 and reviewed by the FDA Dental panel.
Leading manufacturers include Nakanishi, Inc., Foshan Topmed Dental Co., Ltd. and Saeshin Precision Co., Ltd..
FDA 510(k) Cleared Handpiece, Air-powered, Dental Devices (Product Code EFB)
About Product Code EFB - Regulatory Context
510(k) Submission Activity
261 total 510(k) submissions under product code EFB since 1976, with 261 receiving FDA clearance (average review time: 166 days).
Submission volume has declined in recent years - 6 submissions in the last 24 months compared to 11 in the prior period.
FDA Review Time
Recent submissions under EFB have taken an average of 216 days to reach a decision - up from 164 days historically. Manufacturers should account for longer review timelines in current project planning.
EFB devices are reviewed by the Dental panel. Browse all Dental devices →