FDA 510(k) Application Details - K191497

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K191497
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	Vertex-Dental BV Centurionbaan 190 Soesterberg 3769 AV NL Other 510(k) Applications for this Company
Contact	Loes Vloet-Emonts 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	06/05/2019
Decision Date	11/01/2019
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