FDA 510(k) Application Details - K191111

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K191111
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	Dental Direkt GmbH Industriezentrum 106-108 Spenge 32139 DE Other 510(k) Applications for this Company
Contact	Gerhard de Boer 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	04/26/2019
Decision Date	01/11/2023
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