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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K241568
Device Name CrystLCare™ PRO Biorestorative, Fluoride-Plus
Applicant
GreenMark Biomedical, Inc.
325 E Grand River Ave.
Suite 314
East Lansing,  MI  48823
Applicant Contact Steven Bloembergen
Correspondent
in2being, LLC
131 E Michigan Ave.
Suite E
Saline,  MI  48176
Correspondent Contact Rick Routson
Regulation Number872.3260
Classification Product Code
LBH  
Date Received05/31/2024
Decision Date 01/02/2025
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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