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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleanser, Root Canal
510(k) Number K193409
Device Name Vista Rinse, Vista Rinse Plus
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
Classification Product Code
KJJ  
Date Received12/09/2019
Decision Date 09/09/2020
Decision Substantially Equivalent (SESE)
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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