FDA 510(k) Application Details - K153758

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K153758
Device Name	Implant, Endosseous, Root-Form
Applicant	INSTITUT STRAUMANN AG PETER MERIAN-WEG 12 BASEL CH-4002 CH Other 510(k) Applications for this Company
Contact	Christopher Klaczyk 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	12/30/2015
Decision Date	03/23/2016
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