FDA 510(k) Application Details - K160581

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K160581
Device Name	Implant, Endosseous, Root-Form
Applicant	ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG MAINZER STR 346 BINGEN AM RHEIN 55411 DE Other 510(k) Applications for this Company
Contact	RICHARD DONACA 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	03/01/2016
Decision Date	03/24/2017
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