FDA 510(k) Application Details - K160828

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K160828
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	DENTIUM CO., LTD. 150, EONDONG-RO, GIHEUNG-GU Yongin-si 443-270 KR Other 510(k) Applications for this Company
Contact	Sangpil Yoon Other 510(k) Applications for this Contact
Regulation Number	872.3630   More FDA Info for this Regulation Number
Classification Product Code	NHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/25/2016
Decision Date	09/15/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review