FDA 510(k) Application Details - K212541

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K212541
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	DeltaMed GmbH Raiffeisenstrasse 8a Friedberg 61169 DE Other 510(k) Applications for this Company
Contact	Michael Zimmermann 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	08/12/2021
Decision Date	01/10/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review