Home / 510(k) Clearances / K190220

510(k) K190220

Vista FS, Vista FS Liquid by Inter-Med/Vista Dental Products — Product Code MVL

K190220 is an FDA 510(k) premarket notification submitted by Inter-Med/Vista Dental Products for the device "Vista FS, Vista FS Liquid". The FDA issued a decision of Substantially Equivalent on June 10, 2019. The device falls under product code MVL (Cord, Retraction), a Class U device. Inter-Med/Vista Dental Products has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2019
Date Received
February 5, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cord, Retraction
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances by Inter-Med/Vista Dental Products

  • K193357 — V-Mix (October 23, 2020)
  • K193409 — Vista Rinse, Vista Rinse Plus (September 9, 2020)
  • K193447 — Vista Dyes (March 11, 2020)
  • K193389 — Vista Clear (March 4, 2020)
  • K170101 — Valiant Curing Light (June 8, 2017)

Other clearances for product code MVL

  • K254239 — CyClean Cord (March 27, 2026)
  • K253797 — One-Stop (February 27, 2026)
  • K243910 — Retraxil (September 24, 2025)
  • K211420 — Stasis Gel (March 14, 2022)
  • K211419 — Gingi-Aid Gel (January 10, 2022)
  • K213149 — VOCO Retraction Paste (December 9, 2021)
  • K200764 — STATSTIX (October 15, 2020)
  • K193389 — Vista Clear (March 4, 2020)
  • K171577 — Smartcord, Smartcord X (May 3, 2018)
  • K162662 — GingiDent Gingival Retraction Paste (October 20, 2017)

FDA data resources