510(k) K082973

STER-MATE STERILE LAVAGE KIT by Dentsply Interntional — Product Code ELC

K082973 is an FDA 510(k) premarket notification submitted by Dentsply Interntional for the device "STER-MATE STERILE LAVAGE KIT". The FDA issued a decision of Substantially Equivalent on January 29, 2009. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Dentsply Interntional has at least 10 other 510(k) clearances on record.