510(k) K962543

ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU by Nsk Nakanishi, Inc. — Product Code EFB

K962543 is an FDA 510(k) premarket notification submitted by Nsk Nakanishi, Inc. for the device "ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU". The FDA issued a decision of Substantially Equivalent on September 11, 1996. 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.