Cleared Traditional

K193389 - Vista Clear (FDA 510(k) Clearance)

K193389 · Inter-Med/Vista Dental Products · Dental device
Mar 2020
Decision
89d
Days
-
Risk

K193389 is an FDA 510(k) clearance for the Vista Clear. This device is classified as a Cord, Retraction.

Submitted by Inter-Med/Vista Dental Products (Racine, US). The FDA issued a Cleared decision on March 4, 2020, 89 days after receiving the submission on December 6, 2019.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K193389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2019
Decision Date March 04, 2020
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code MVL - Cord, Retraction
Device Class -