Cleared Traditional

K190220 - Vista FS, Vista FS Liquid (FDA 510(k) Clearance)

Jun 2019
Decision
125d
Days
-
Risk

K190220 is an FDA 510(k) clearance for the Vista FS, Vista FS Liquid. This device is classified as a Cord, Retraction.

Submitted by Inter-Med/Vista Dental Products (Racine, US). The FDA issued a Cleared decision on June 10, 2019, 125 days after receiving the submission on February 5, 2019.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K190220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2019
Decision Date June 10, 2019
Days to Decision 125 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code MVL - Cord, Retraction
Device Class -