FDA 510(k) Application Details - K212125

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K212125
Device Name	Implant, Endosseous, Root-Form
Applicant	Nobel Biocare AG P.O. Box, 8058 Zurich - Airport Balsberg, Balz Zimmermann-Str. 7 8302 CH Other 510(k) Applications for this Company
Contact	Bernice Jim 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	07/07/2021
Decision Date	09/24/2021
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