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 W&H Dentalwerk B?rmoos GmbH.