Cleared Traditional

K193357 - V-Mix (FDA 510(k) Clearance)

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

K193357 is an FDA 510(k) clearance for the V-Mix. This device is classified as 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 FDA review panel.

Submission Details

510(k) Number K193357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 -