510(k) K211584

Oral Surgery Contra by Nakanishi, Inc. — Product Code KMW

K211584 is an FDA 510(k) premarket notification submitted by Nakanishi, Inc. for the device "Oral Surgery Contra". The FDA issued a decision of Substantially Equivalent on August 19, 2021. The device falls under product code KMW (Handpiece, Rotary Bone Cutting), a Class II device regulated under 21 CFR 872.4120. Nakanishi, Inc. has at least 10 other 510(k) clearances on record.