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 Dentsply Intl., Nakanishi, Inc. and Parkell, Inc..