510(k) K791585

MODEL G-61 ULTRASONIC DENTAL UNIT by Cavitron Corp. — Product Code ELC

K791585 is an FDA 510(k) premarket notification submitted by Cavitron Corp. for the device "MODEL G-61 ULTRASONIC DENTAL UNIT". The FDA issued a decision of Substantially Equivalent on September 19, 1979. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Cavitron Corp. has at least 10 other 510(k) clearances on record.