FDA 510(k) Application Details - K210117

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K210117
Device Name	Implant, Endosseous, Root-Form
Applicant	Paltop Advanced Dental Solutions, Ltd Hashita 5, Industrial Park Caesarea 3088900 IL Other 510(k) Applications for this Company
Contact	Zina Gurgov 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	01/19/2021
Decision Date	11/30/2021
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