FDA 510(k) Application Details - K171007

Device Classification Name	Laser,Fluorescence Caries Detection   More FDA Info for this Device
510(K) Number	K171007
Device Name	Laser,Fluorescence Caries Detection
Applicant	Carl Zeiss Suzhou Co., Ltd. Modern Industrial Square 3b No. 333 Xing Pu Road Sip Suzhou 215126 CN Other 510(k) Applications for this Company
Contact	Huang XiaoDong 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	04/04/2017
Decision Date	05/03/2018
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