510(k) K093221

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II by Dentsply Intl., Inc. — Product Code DYH

K093221 is an FDA 510(k) premarket notification submitted by Dentsply Intl., Inc. for the device "PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II". The FDA issued a decision of Substantially Equivalent on October 30, 2009. The device falls under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin), a Class II device regulated under 21 CFR 872.3750. Dentsply Intl., Inc. has at least 10 other 510(k) clearances on record.