FDA 510(k) Application Details - K233616

Device Classification Name	More FDA Info for this Device
510(K) Number	K233616
Device Name	Clevaligner Software (V1.0.0)
Applicant	Clevaligner Ltd King George St 20 Jerusalem 9426208 IL Other 510(k) Applications for this Company
Contact	Jonathan Tabet 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	11/13/2023
Decision Date	01/11/2024
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