FDA 510(k) Application Details - K170372

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K170372
Device Name	Implant, Endosseous, Root-Form
Applicant	SpiralTech Superior Dental Implants, Inc. 875 N Michigan Avenue, Suite 3106 Chicago, IL 60611 US Other 510(k) Applications for this Company
Contact	Daniel Rosenthal 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	02/07/2017
Decision Date	06/30/2017
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