FDA 510(k) Application Details - K162436

Device Classification Name	Handpiece, Air-Powered, Root Canal Irrigation   More FDA Info for this Device
510(K) Number	K162436
Device Name	Handpiece, Air-Powered, Root Canal Irrigation
Applicant	Kerr Corporation 1717 W. Collins Ave Orange, CA 92867 US Other 510(k) Applications for this Company
Contact	Mohammad Saad Ansari Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	NYL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/31/2016
Decision Date	12/21/2016
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