510(k) K052334

CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 by Dentsply Intl. — Product Code ELC

K052334 is an FDA 510(k) premarket notification submitted by Dentsply Intl. for the device "CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131". The FDA issued a decision of Substantially Equivalent on Sep 2, 2005. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Dentsply Intl. has 290 other 510(k) clearances on record.