FDA 510(k) Application Details - K072754

Device Classification Name	Handpiece, Air-Powered, Dental   More FDA Info for this Device
510(K) Number	K072754
Device Name	Handpiece, Air-Powered, Dental
Applicant	AXENIC DENTAL, INC. 259 EAST MICHIGAN AVE. SUITE 409 KALAMAZOO, MI 49007 US Other 510(k) Applications for this Company
Contact	JOSEPH T SOBOTA Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EFB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2007
Decision Date	01/25/2008
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