Vista Dyes

Device, Caries Detection

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 Dyes.

Pre-market Notification Details

Device IDK193447
510k NumberK193447
Device Name:Vista Dyes
ClassificationDevice, Caries Detection
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 CodeLFC  
CFR Regulation Number872.1740 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-13
Decision Date2020-03-11

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