FDA 510(k) Application Details - K053167

Device Classification Name	Cleanser, Root Canal   More FDA Info for this Device
510(K) Number	K053167
Device Name	Cleanser, Root Canal
Applicant	DENTSPLY INTL., INC. SUSQUEHANNA COMMERCE CENTER 221W PHILADELPHIA ST. SUITE 60 YORK, PA 17404 US Other 510(k) Applications for this Company
Contact	HELEN LEWIS Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	KJJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2005
Decision Date	12/08/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review