FDA 510(k) Application Details - K120089

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K120089
Device Name	Implant, Endosseous, Root-Form
Applicant	BIOGENESIS CO., LTD. 1515 EAST KATELLA AVENUE UNIT 2115 ANAHEIM, CA 92805 US Other 510(k) Applications for this Company
Contact	Priscilla Chung 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	01/11/2012
Decision Date	03/13/2013
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