510(k) K061383

BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS by B.T.I. Biotechnology Institute, Sl. — Product Code EJL

K061383 is an FDA 510(k) premarket notification submitted by B.T.I. Biotechnology Institute, Sl. for the device "BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS". The FDA issued a decision of Substantially Equivalent on August 3, 2006. The device falls under product code EJL (Bur, Dental), a Class I device regulated under 21 CFR 872.3240. B.T.I. Biotechnology Institute, Sl. has at least 10 other 510(k) clearances on record.