Cleared Traditional

Vista Rinse, Vista Rinse Plus

Sep 2020
Decision
275d
Days
Risk

About This 510(k) Submission

K193409 is an FDA 510(k) clearance for the Vista Rinse, Vista Rinse Plus, a Cleanser, Root Canal, submitted by Inter-Med/Vista Dental Products (Racine, US). The FDA issued a Cleared decision on September 9, 2020, 275 days after receiving the submission on December 9, 2019. This device falls under the Dental review panel.

Submission Details

510(k) Number K193409 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2019
Decision Date September 09, 2020
Days to Decision 275 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KJJ — Cleanser, Root Canal
Device Class