510(k) K130862

CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM by Dentsply Intl., Inc. — Product Code ELC

K130862 is an FDA 510(k) premarket notification submitted by Dentsply Intl., Inc. for the device "CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM". The FDA issued a decision of Substantially Equivalent on July 23, 2013. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Dentsply Intl., Inc. has at least 10 other 510(k) clearances on record.