510(k) K053010

VISTADENT AT COMPLETE, MODEL 3.1 by Dentsply Intl., Inc. — Product Code LLZ

K053010 is an FDA 510(k) premarket notification submitted by Dentsply Intl., Inc. for the device "VISTADENT AT COMPLETE, MODEL 3.1". The FDA issued a decision of Substantially Equivalent on November 22, 2005. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Dentsply Intl., Inc. has at least 10 other 510(k) clearances on record.