FDA 510(k) Application Details - K191382

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K191382
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	Ivoclar Vivadent, AG Bendererstrasse 2 Schaan FL-9494 LI Other 510(k) Applications for this Company
Contact	Sandra Cakebread 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	05/23/2019
Decision Date	08/26/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review