510(k) K071055

OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 by Ultradent Products, Inc. — Product Code DYW

K071055 is an FDA 510(k) premarket notification submitted by Ultradent Products, Inc. for the device "OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802". The FDA issued a decision of Substantially Equivalent on May 3, 2007. The device falls under product code DYW (Bracket, Plastic, Orthodontic), a Class II device regulated under 21 CFR 872.5470. Ultradent Products, Inc. has at least 10 other 510(k) clearances on record.