FDA 510(k) Application Details - K231529

Device Classification Name	More FDA Info for this Device
510(K) Number	K231529
Device Name	CloudPoint FastDesign Chairside
Applicant	Prismatik Dentalcraft, Inc. 2144 Michelson Drive Irvine, CA 92612 US Other 510(k) Applications for this Company
Contact	Jiahe Li Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/2023
Decision Date	03/14/2024
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