510(k) K040547

AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE by Harry J. Bosworth Co. — Product Code DYH

K040547 is an FDA 510(k) premarket notification submitted by Harry J. Bosworth Co. for the device "AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE". The FDA issued a decision of Substantially Equivalent on March 19, 2004. The device falls under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin), a Class II device regulated under 21 CFR 872.3750. Harry J. Bosworth Co. has at least 10 other 510(k) clearances on record.