FDA 510(k) Application Details - K240573

Device Classification Name	Caries Detector, Laser Light, Transmission   More FDA Info for this Device
510(K) Number	K240573
Device Name	Caries Detector, Laser Light, Transmission
Applicant	Align Technology Ltd. 1 Yitzhak Rabin Rd. Petach Tikva 4925110 IL Other 510(k) Applications for this Company
Contact	Aviva Touati Other 510(k) Applications for this Contact
Regulation Number	872.1745   More FDA Info for this Regulation Number
Classification Product Code	NTK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2024
Decision Date	08/16/2024
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