FDA 510(k) Application Details - K211921

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K211921
Device Name	Implant, Endosseous, Root-Form
Applicant	S.I.N. - Sistema de Implante Nacional S.A. Avenida Vereador Abel Ferreira, 1100 Sπo Paulo 03340-000 BR Other 510(k) Applications for this Company
Contact	Denise Domiciano 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	06/21/2021
Decision Date	10/20/2021
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