510(k) K103585

BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP by Harry J. Bosworth Co. — Product Code EMA

K103585 is an FDA 510(k) premarket notification submitted by Harry J. Bosworth Co. for the device "BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP". The FDA issued a decision of Substantially Equivalent on March 4, 2011. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Harry J. Bosworth Co. has at least 10 other 510(k) clearances on record.