FDA 510(k) Application Details - K202452

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K202452
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	Nobel Biocare AB Vastra Hamngatan 1 Goteborg Gotlands Lan 411 17 SE Other 510(k) Applications for this Company
Contact	Bernice Jim Other 510(k) Applications for this Contact
Regulation Number	872.3630   More FDA Info for this Regulation Number
Classification Product Code	NHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2020
Decision Date	12/03/2020
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