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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light-Induced Fluorescence Caries Detector
510(k) Number K171007
Device Name Fluorescence Mode
Applicant
Carl Zeiss Suzhou Co., Ltd.
Modern Industrial Sq. 3b, # 333 Xing Pu Rd. Sip
Suzhou,  CN 215126
Applicant Contact Huang XiaoDong
Correspondent
Carl Zeiss Meditec, Inc.
5160 Hacienda Dr.
Dublin,  CA  94568
Correspondent Contact Mandy Ambrecht
Regulation Number872.1745
Classification Product Code
NBL  
Date Received04/04/2017
Decision Date 05/03/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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