510(k) K092030

ELATION MB METAL REINFORCED PLASTIC BRACKET by Dentsply Interntional — Product Code DYW

K092030 is an FDA 510(k) premarket notification submitted by Dentsply Interntional for the device "ELATION MB METAL REINFORCED PLASTIC BRACKET". The FDA issued a decision of Substantially Equivalent on July 24, 2009. The device falls under product code DYW (Bracket, Plastic, Orthodontic), a Class II device regulated under 21 CFR 872.5470. Dentsply Interntional has at least 10 other 510(k) clearances on record.