FDA 510(k) Application Details - K181112

Device Classification Name	More FDA Info for this Device
510(K) Number	K181112
Device Name	Orchestrate 3D
Applicant	Orchestrate 3D 1747 North Riverside Ave Rialto, CA 92376 US Other 510(k) Applications for this Company
Contact	Todd Ehrler Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2018
Decision Date	11/26/2018
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