Vista Rinse, Vista Rinse Plus

Cleanser, Root Canal

Inter-Med/Vista Dental Products

The following data is part of a premarket notification filed by Inter-med/vista Dental Products with the FDA for Vista Rinse, Vista Rinse Plus.

Pre-market Notification Details

Device IDK193409
510k NumberK193409
Device Name:Vista Rinse, Vista Rinse Plus
ClassificationCleanser, Root Canal
Applicant Inter-Med/Vista Dental Products 2200 South St. Ste. A Racine,  WI  53404
ContactAlex Johnson
CorrespondentAlex Johnson
Inter-Med/Vista Dental Products 2200 South St. Ste. A Racine,  WI  53404
Product CodeKJJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-09
Decision Date2020-09-09

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