FDA 510(k) Application Details - K202344

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K202344
Device Name	Implant, Endosseous, Root-Form
Applicant	Nobel Biocare AB Box 5190, SE-402 26 Vastra Hamngatan 1 411 17 SE 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	08/18/2020
Decision Date	11/16/2020
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