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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activator, Ultraviolet, For Polymerization
510(k) Number K241238
Device Name LOOP™ LED Curing Light System (CLK01)
Applicant
Garrison Dental Solutions, LLC
150 Dewitt Lane
Spring Lake,  MI  49456
Applicant Contact Rhonda Allen
Correspondent
Regulatory Affairs Associates, LLC
4761 Tara Court
West Bloomfield,  MI  48323
Correspondent Contact Michael Tomasovich
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received05/03/2024
Decision Date 08/01/2024
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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