510(k) K100647

A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM by A-Dec, Inc. — Product Code ELC

K100647 is an FDA 510(k) premarket notification submitted by A-Dec, Inc. for the device "A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM". The FDA issued a decision of Substantially Equivalent on July 9, 2010. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. A-Dec, Inc. has at least 10 other 510(k) clearances on record.