Cleared Traditional

K190220 - Vista FS

K190220 · Inter-Med/Vista Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
125d
Days
-
Risk

K190220 is an FDA 510(k) clearance for the Vista FS, Vista FS Liquid. Classified as Cord, Retraction (product code MVL).

Submitted by Inter-Med/Vista Dental Products (Racine, US). The FDA issued a Cleared decision on June 10, 2019 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Inter-Med/Vista Dental Products devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 127d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 14
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K190220.
VOCO Retraction Paste
K213149 · Voco GmbH · Dec 2021
STATSTIX
K200764 · Centrix Incorporated · Oct 2020
Vista Clear
K193389 · Inter-Med/Vista Dental Products · Mar 2020
Smartcord, Smartcord X
K171577 · Eastdent Co., Ltd. · May 2018
Astringedent Clear
K152064 · Ultradent Products, Inc. · Sep 2015
VISCOSTAT CLEAR
K123215 · Ultradent Products, Inc. · Feb 2013