FDA 510(k) Application Details - K142751

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K142751
Device Name	Implant, Endosseous, Root-Form
Applicant	Chang Gung Medical Technology Co., Ltd. 11F., No. 201-4, Dun Hua North Rd. Song Shan Dist Taipei City 10508 TW Other 510(k) Applications for this Company
Contact	Chao-Chun Chiu 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	09/24/2014
Decision Date	06/15/2015
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