FDA 510(k) Application Details - K192846

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K192846
Device Name	Aligner, Sequential
Applicant	Argen Corporation 5855 Oberlin Drive San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Paul Cascone Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	NXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2019
Decision Date	02/10/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review