FDA 510(k) Application Details - K222560

Device Classification Name	Device, Caries Detection   More FDA Info for this Device
510(K) Number	K222560
Device Name	Device, Caries Detection
Applicant	Incisive Technologies Pty Ltd Level 4, 71 Collins Street Melbourne 3000 AU Other 510(k) Applications for this Company
Contact	Kerry A Hegarty Other 510(k) Applications for this Contact
Regulation Number	872.1740   More FDA Info for this Regulation Number
Classification Product Code	LFC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2022
Decision Date	05/16/2023
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