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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 K193447
Device Name Vista Dyes
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 Number872.1740
Classification Product Code
LFC  
Date Received12/13/2019
Decision Date 03/11/2020
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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