FDA 510(k) Application Details - K191926

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K191926
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	VITA Zanhnfabrik H. Rauter GmbH Co. Spitelgasse 3 Bad Sackingen D-79713 DE Other 510(k) Applications for this Company
Contact	Bernd Walker 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	07/18/2019
Decision Date	01/29/2020
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