Vista FS, Vista FS Liquid

FDA 510(k) K190220 · Inter-Med/Vista Dental Products

Substantially Equivalent

510(k) numberK190220

Submission

Device name
Vista FS, Vista FS Liquid
Applicant
Inter-Med/Vista Dental Products
Racine, WI, US
Received
February 5, 2019
Decision date
June 10, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MVL – Cord, Retraction
Device class
Unclassified

Other 510(k)s with product code MVL

510(k)DeviceApplicantDecision
K254239CyClean CordMVL · Traditional SS Global03/27/2026SE
K253797One-StopMVL · Traditional Mediclus Co., Ltd.02/27/2026SE
K243910RetraxilMVL · Traditional Kulzer, LLC09/24/2025SE
K211420Stasis GelMVL · Traditional Belport Company, Inc., Gingi-Pak03/14/2022SE
K211419Gingi-Aid GelMVL · Traditional Belport Company, Inc., Gingi-Pak01/10/2022SE
K213149VOCO Retraction PasteMVL · Traditional Voco GmbH12/09/2021SE
K200764StatstixMVL · Traditional Centrix Incorporated10/15/2020SE
K193389Vista ClearMVL · Traditional Inter-Med/Vista Dental Products03/04/2020SE
K171577Smartcord, Smartcord XMVL · Traditional Eastdent Co., Ltd.05/03/2018SE
K162662GingiDent Gingival Retraction PasteMVL · Traditional Pac-Dent International, Inc.10/20/2017SE

More from Pac-Dent International, Inc.

510(k)DeviceDecision
K193357V-MixKJJ · Traditional 10/23/2020SE
K193409Vista Rinse, Vista Rinse PlusKJJ · Traditional 09/09/2020SE
K193447Vista DyesLFC · Traditional 03/11/2020SE
K193389Vista ClearMVL · Traditional 03/04/2020SE
K170101Valiant Curing LightEBZ · Traditional 06/08/2017SE

Questions and answers

When was Vista FS, Vista FS Liquid cleared by the FDA?

Vista FS, Vista FS Liquid (K190220) received a 510(k) decision of Substantially Equivalent on June 10, 2019, 125 days after the submission was received.

What is the product code of K190220?

The FDA product code is MVL – Cord, Retraction, a Unclassified device.