FDA 510(k) Application Details - K162044

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K162044
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	DENTCA, Inc. 357 Van Ness Way #250 Torrance, CA 90501 US Other 510(k) Applications for this Company
Contact	Jason Lee 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	07/25/2016
Decision Date	03/03/2017
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