FDA 510(k) Application Details - K221249

Device Classification Name	Laser,Fluorescence Caries Detection   More FDA Info for this Device
510(K) Number	K221249
Device Name	Laser,Fluorescence Caries Detection
Applicant	3Shape TRIOS A/S Holmens Kanal 7 Copenhagen K Dk-1060 DK Other 510(k) Applications for this Company
Contact	Klaus Rudbaek Hoj Other 510(k) Applications for this Contact
Regulation Number	872.1745   More FDA Info for this Regulation Number
Classification Product Code	NBL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2022
Decision Date	09/16/2022
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