FDA 510(k) Application Details - K142813

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K142813
Device Name	Implant, Endosseous, Root-Form
Applicant	BIOGENESIS CO., LTD. Mecha Zone #1109, SK Techno Park,50, Wanam-Ro, Seongsan Changwon-Si 642-971 KR Other 510(k) Applications for this Company
Contact	Haeyong Lee 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	09/29/2014
Decision Date	07/31/2015
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