FDA 510(k) Application Details - K212173

Device Classification Name	More FDA Info for this Device
510(K) Number	K212173
Device Name	HDH Treatment Planning System
Applicant	CDB Corporation 9201 Industrial Park Boulevard Leland, NC 28451 US Other 510(k) Applications for this Company
Contact	Leah M Lehman 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	07/12/2021
Decision Date	01/25/2022
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