FDA 510(k) Application Details - K190406

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K190406
Device Name	Implant, Endosseous, Root-Form
Applicant	SDS Swiss Dental Solutions AG Konstanzerstrasse 11 Kreuzlingen 8280 CH Other 510(k) Applications for this Company
Contact	Martin Chares 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	02/21/2019
Decision Date	02/20/2020
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