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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 K170101
Device Name Valiant Curing Light
Applicant
Inter-Med/Vista Dental Products
2200 S. St. Suite A
Racine,  WI  53404
Applicant Contact Alex Johnson
Correspondent
Inter-Med/Vista Dental Products
2200 S. St. Suite A
Racine,  WI  53404
Correspondent Contact Alex Johnson
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received01/11/2017
Decision Date 06/08/2017
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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