510(k) K881253

ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW by Dentalez Group — Product Code ELC

K881253 is an FDA 510(k) premarket notification submitted by Dentalez Group for the device "ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW". The FDA issued a decision of Substantially Equivalent on April 21, 1988. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Dentalez Group has at least 10 other 510(k) clearances on record.