CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131

About This 510(k) Submission

K052334 is an FDA 510(k) clearance for the CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on September 2, 2005, 7 days after receiving the submission on August 26, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.