Cleared Traditional

Vista Dyes

K193447 · Inter-Med/Vista Dental Products · Dental
Mar 2020
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K193447 is an FDA 510(k) clearance for the Vista Dyes, a Device, Caries Detection (Class II — Special Controls, product code LFC), submitted by Inter-Med/Vista Dental Products (Racine, US). The FDA issued a Cleared decision on March 11, 2020, 89 days after receiving the submission on December 13, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.1740.

Submission Details

510(k) Number K193447 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2019
Decision Date March 11, 2020
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LFC — Device, Caries Detection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1740