FDA 510(k) Application Details - K213159

Device Classification Name	More FDA Info for this Device
510(K) Number	K213159
Device Name	Encore System
Applicant	Siesta Medical, Inc. 101 Church Street Los Gatos, CA 95030 US Other 510(k) Applications for this Company
Contact	Michael Kolber Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	ORY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2021
Decision Date	12/22/2021
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