FDA 510(k) Application Details - K190662

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K190662
Device Name	Implant, Endosseous, Root-Form
Applicant	Straumann USA LLC 60 Minuteman Road Andover, MA 01810 US Other 510(k) Applications for this Company
Contact	Loretta Kushner-Mooney 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	03/15/2019
Decision Date	06/17/2019
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