FDA 510(k) Application Details - K172398

Device Classification Name	More FDA Info for this Device
510(K) Number	K172398
Device Name	DENTCA DENTURE Teeth
Applicant	DENTCA, INC. 357 Van Ness Way, Suite 250 Torrance, CA 90501 US Other 510(k) Applications for this Company
Contact	Jason Lee Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2017
Decision Date	11/22/2017
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