Cleared Traditional

V-Mix

K193357 · Inter-Med/Vista Dental Products · Dental
Oct 2020
Decision
324d
Days
—
Risk

About This 510(k) Submission

K193357 is an FDA 510(k) clearance for the V-Mix, a Cleanser, Root Canal, submitted by Inter-Med/Vista Dental Products (Racine, US). The FDA issued a Cleared decision on October 23, 2020, 324 days after receiving the submission on December 4, 2019. This device falls under the Dental review panel.

Submission Details

510(k) Number K193357 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2019
Decision Date October 23, 2020
Days to Decision 324 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KJJ — Cleanser, Root Canal
Device Class —