FDA 510(k) Application Details - K153268

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K153268
Device Name	Implant, Endosseous, Root-Form
Applicant	DENTIUM CO., LTD. 29 TEHERAN-RO, 87-GZL GANGNAM-GU SEOUL 06167 KR Other 510(k) Applications for this Company
Contact	YOUNJUNG YUK 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	11/12/2015
Decision Date	07/20/2016
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