FDA 510(k) Application Details - K151588

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K151588
Device Name	Implant, Endosseous, Root-Form
Applicant	Taiwan Implant Technology Company, Ltd. Kaohsiung Science Park Branch 5F., No.63, Luke 2nd Rd., Luzhu Dist Kaohsiung 82151 TW Other 510(k) Applications for this Company
Contact	Ching-Chieh Huang 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	06/11/2015
Decision Date	04/25/2016
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