FDA 510(k) Application Details - K133255

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K133255
Device Name	Implant, Endosseous, Root-Form
Applicant	DENTALPOINT AG 4 INNOVATION DRIVE DUNDAS, ON L9H 7P3 CA Other 510(k) Applications for this Company
Contact	ROSHANA AHMED Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2013
Decision Date	08/12/2014
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