510(k) K971774

NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION by Nsk Nakanishi, Inc. — Product Code EFB

K971774 is an FDA 510(k) premarket notification submitted by Nsk Nakanishi, Inc. for the device "NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION". The FDA issued a decision of Substantially Equivalent on June 20, 1997. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Nsk Nakanishi, Inc. has at least 10 other 510(k) clearances on record.