510(k) K252662

UniBur by Nakanishi, Inc. — Product Code HBE

K252662 is an FDA 510(k) premarket notification submitted by Nakanishi, Inc. for the device "UniBur". The FDA issued a decision of Substantially Equivalent on September 19, 2025. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. Nakanishi, Inc. has at least 10 other 510(k) clearances on record.