FDA 510(k) Application Details - K150388

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K150388
Device Name	Implant, Endosseous, Root-Form
Applicant	BIO CONCEPT CO., LTD UNIT C, NO. 26, HUASHAN MIDDLE ROAD, XINBEI ZONE CHANGZHOU 213022 CN Other 510(k) Applications for this Company
Contact	HUA CAO 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	02/18/2015
Decision Date	11/12/2015
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