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., Essential Dental Systems, Inc. and Mectron S.P.A..
FDA 510(k) Cleared Scaler, Ultrasonic Devices (Product Code ELC)
About Product Code ELC - Regulatory Context
510(k) Submission Activity
195 total 510(k) submissions under product code ELC since 1976, with 195 receiving FDA clearance (average review time: 138 days).
Submission volume has remained relatively stable over the observed period, with 7 submissions in the last 24 months.
FDA Review Time
FDA review times for ELC submissions have been consistent, averaging 125 days recently vs 138 days historically.
ELC devices are reviewed by the Dental panel. Browse all Dental devices →