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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 K172426
Device Name Clear Blue Digi LED Curing Light
Applicant
Promident, LLC
618 Corporate Way Unit 1
Valley Cottage,  NY  10989
Applicant Contact Gary Kris
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received08/10/2017
Decision Date 08/16/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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