510(k) K130693

AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM by Aseptico, Inc. — Product Code ELC

K130693 is an FDA 510(k) premarket notification submitted by Aseptico, Inc. for the device "AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM". The FDA issued a decision of Substantially Equivalent on August 14, 2013. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Aseptico, Inc. has at least 10 other 510(k) clearances on record.