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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, caries detection
510(k) Number K200601
Device Name LumiCare Caries Diagnostic Rinse
Applicant
GreenMark Biomedical Inc.
325 E. Grand River Ave., Suite 314
East Lansing,  MI  48823
Applicant Contact Steven Bloembergen
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.1740
Classification Product Code
LFC  
Subsequent Product Code
EAQ  
Date Received03/09/2020
Decision Date 03/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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