510(k) K240262

BTI Interna 3.0 Dental Implant System UnicCa® by B.T.I. Biotechnology Institute, Sl. — Product Code DZE

K240262 is an FDA 510(k) premarket notification submitted by B.T.I. Biotechnology Institute, Sl. for the device "BTI Interna 3.0 Dental Implant System UnicCa®". The FDA issued a decision of Substantially Equivalent on October 10, 2024. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. B.T.I. Biotechnology Institute, Sl. has at least 10 other 510(k) clearances on record.