510(k) K081291

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION by Dentsply Interntional — Product Code DYH

K081291 is an FDA 510(k) premarket notification submitted by Dentsply Interntional for the device "PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION". The FDA issued a decision of Substantially Equivalent on May 22, 2008. The device falls under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin), a Class II device regulated under 21 CFR 872.3750. Dentsply Interntional has at least 10 other 510(k) clearances on record.