510(k) K150535

Cavitron Touch Ultrasonic Scaling System by Dentsply International, Inc. — Product Code ELC

K150535 is an FDA 510(k) premarket notification submitted by Dentsply International, Inc. for the device "Cavitron Touch Ultrasonic Scaling System". The FDA issued a decision of Substantially Equivalent on June 16, 2015. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Dentsply International, Inc. has at least 10 other 510(k) clearances on record.