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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Fluorescence Caries Detection
510(k) Number K171007
Device Name Fluorescence Mode
Applicant
Carl Zeiss Suzhou Co., Ltd.
Modern Industrial Square 3b
No. 333 Xing Pu Road Sip
Suzhou,  CN 215126
Applicant Contact Huang XiaoDong
Correspondent
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
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
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