FDA 510(k) Application Details - K160398

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K160398
Device Name	Implant, Endosseous, Root-Form
Applicant	Zimmer Dental, Inc. 1900 Aston Ave. Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Alex Eastes 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	02/12/2016
Decision Date	05/17/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review