EFB · Class I · 21 CFR 872.4200

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..

4
Total
4
Cleared
224d
Avg days
2022
Since

List of Handpiece, Air-powered, Dental devices cleared through 510(k)

4 devices
1–4 of 4
Cleared Sep 20, 2024
Air Powered Tooth Polishing System (Perio-Mate)
K241880
Nakanishi, Inc.
Dental · 84d
Cleared Apr 25, 2024
Air Motor (Model name: FX204 M4)
K233308
Nakanishi, Inc.
Dental · 209d
Cleared Jun 02, 2023
Titanium Turbine
K230888
Nakanishi, Inc.
Dental · 63d
Cleared Jun 21, 2022
Stainless Turbine
K203791
Nakanishi, Inc.
Dental · 540d

How to use this database

This page lists all FDA 510(k) submissions for Handpiece, Air-powered, Dental devices (product code EFB). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Dental FDA review panel. Browse all Dental devices →