FDA 510(k) Application Details - K140806

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K140806
Device Name	Implant, Endosseous, Root-Form
Applicant	INNOBIOSURG CO., LTD 12226 WASHINGTON LANE PARKER, AZ 85344 US Other 510(k) Applications for this Company
Contact	CHARLIE MACK 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	04/01/2014
Decision Date	03/23/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review