FDA Product Code ELC: Scaler, Ultrasonic
Ultrasonic scaling provides efficient, minimally invasive removal of dental calculus. FDA product code ELC covers ultrasonic dental scalers used for periodontal treatment.
These instruments use high-frequency vibration at the scaler tip to mechanically disrupt and remove calculus, plaque biofilm, and stain from tooth surfaces and within periodontal pockets. They are more efficient than hand scaling for supragingival and subgingival debridement.
ELC devices are Class II medical devices, regulated under 21 CFR 872.4850 and reviewed by the FDA Dental panel.
Leading manufacturers include Nakanishi, Inc. and E.M.S Electro Medical Systems S.A.
List of Scaler, Ultrasonic devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Scaler, Ultrasonic devices (product code ELC). 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 →