FDA 510(k) Application Details - K180365

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K180365
Device Name	Implant, Endosseous, Root-Form
Applicant	Sweden & Martina S.p.A. via Veneto 10 Due Carrare 35020 IT Other 510(k) Applications for this Company
Contact	Alessia Pezzato 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	02/12/2018
Decision Date	07/08/2019
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