FDA 510(k) Application Details - K110278

Device Classification Name	Handpiece, Direct Drive, Ac-Powered   More FDA Info for this Device
510(K) Number	K110278
Device Name	Handpiece, Direct Drive, Ac-Powered
Applicant	NAKANISHI, INC. 1201 RICHARDSON DRIVE SUITE 280 RICHARDSON, TX 75080 US Other 510(k) Applications for this Company
Contact	DIANE RUTHERFORD Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2011
Decision Date	02/15/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review