FDA 510(k) Application Details - K192742

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K192742
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	Institut Straumann AG Lochhamer Schlag 6 Grafelfing 82166 DE Other 510(k) Applications for this Company
Contact	Gordon Dodds 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	09/30/2019
Decision Date	02/12/2021
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