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510(k) K193357

V-Mix by Inter-Med/Vista Dental Products — Product Code KJJ

K193357 is an FDA 510(k) premarket notification submitted by Inter-Med/Vista Dental Products for the device "V-Mix". The FDA issued a decision of Substantially Equivalent on October 23, 2020. The device falls under product code KJJ (Cleanser, Root Canal), 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
October 23, 2020
Date Received
December 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleanser, Root Canal
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances by Inter-Med/Vista Dental Products

  • K193409 — Vista Rinse, Vista Rinse Plus (September 9, 2020)
  • K193447 — Vista Dyes (March 11, 2020)
  • K193389 — Vista Clear (March 4, 2020)
  • K190220 — Vista FS, Vista FS Liquid (June 10, 2019)
  • K170101 — Valiant Curing Light (June 8, 2017)

Other clearances for product code KJJ

  • K250279 — RC-SwiftPrep (July 2, 2025)
  • K241354 — Sealer Solvent (August 27, 2024)
  • K201785 — EPIEN Dental Cleanser (September 9, 2021)
  • K211813 — Triton (August 18, 2021)
  • K193409 — Vista Rinse, Vista Rinse Plus (September 9, 2020)
  • K200330 — RC-Prime Root Canal Preparation Cream (July 6, 2020)
  • K173163 — ChlorCid, ChlorCid V, ChlorCid Surf (February 9, 2018)
  • K162311 — Straumann PrefGel (March 7, 2017)
  • K160577 — PacEndo Chlorhexidine (July 25, 2016)
  • K153528 — PacEndo EDTA (February 1, 2016)

FDA data resources