510(k) K010176

CALEX CONDITIONER by Stephen M Koral, Dmd — Product Code EJK

K010176 is an FDA 510(k) premarket notification submitted by Stephen M Koral, Dmd for the device "CALEX CONDITIONER". The FDA issued a decision of Substantially Equivalent on March 27, 2001. The device falls under product code EJK (Liner, Cavity, Calcium Hydroxide), a Class II device regulated under 21 CFR 872.3250. Stephen M Koral, Dmd has at least 1 other 510(k) clearance on record.