FDA 510(k) Application Details - K203641

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K203641
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	EnvisionTEC GmbH Brusseler Stra▀e 51 Gladbeck D-45968 DE Other 510(k) Applications for this Company
Contact	Ruediger van Bernum Other 510(k) Applications for this Contact
Regulation Number	872.3760   More FDA Info for this Regulation Number
Classification Product Code	EBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/14/2020
Decision Date	03/30/2021
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