510(k) K233308

Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) by Nakanishi, Inc. — Product Code EFB

K233308 is an FDA 510(k) premarket notification submitted by Nakanishi, Inc. for the device "Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)". The FDA issued a decision of Substantially Equivalent on April 25, 2024. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Nakanishi, Inc. has at least 10 other 510(k) clearances on record.