510(k) Report

FDA applicant

Inter-Med/Vista Dental Products

Racine, WI6 decisions2017–20201 recall

FDA records 6 decisions for Inter-Med/Vista Dental Products (Racine, WI) from 2017 to 2020: 6 510(k) clearances. Most are in product codes KJJ (Cleanser, Root Canal) and MVL (Cord, Retraction). Since 2016 its 510(k)s took a median of 275 days from receipt to decision, against 275 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Inter-Med/Vista Dental Products’s devices, and how often a recall has named them.

FDA decisions per year

4in 2020

2017: 12019: 12020: 4
2017high 4 (2020) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2017high 1 (2026) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Inter-Med/Vista Dental Products by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Inter-Med/Vista Dental Products’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KJJCleanser, Root Canal2decisions
  • MVLCord, Retraction2decisions
  • EBZActivator, Ultraviolet, For Polymerization1decision
  • LFCDevice, Caries Detection1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 275 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 275 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K193389Vista ClearInter-Med/Vista Dental Products · 20202cite it
  • K193357V-MixInter-Med/Vista Dental Products · 20201cites it
  • K193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products · 20201cites it
  • K190220Vista FS, Vista FS LiquidInter-Med/Vista Dental Products · 20191cites it

What has FDA decided for it lately?

  • K193357V-MixInter-Med/Vista Dental Products · 2020
  • K193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products · 2020
  • K193447Vista DyesInter-Med/Vista Dental Products · 2020
  • K193389Vista ClearInter-Med/Vista Dental Products · 2020
  • K190220Vista FS, Vista FS LiquidInter-Med/Vista Dental Products · 20191 recall
  • K170101Valiant Curing LightInter-Med/Vista Dental Products · 2017

All 6 as Inter-Med/Vista Dental Products →

What has been recalled?

1 recall linked to its devices; the latest:

  • K190220Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28May 27, 2026Class II

Other applicant names beginning “Inter-Med/Vista”

FDA records each applicant name separately; these may or may not be the same firm.

Inter-Med, Inc. 12Inter Medical Medizintechnik GmbH 3Inter Med Industries, Inc. 3Inter Science Institute 3Inter-Os Technologies 2Inter Continental Health Care 2Inter-Asia Co., Inc. 1Inter-Pal GmbH 1Inter-Med / Vista Dental 1Inter-Continental Industries Sdn Bhd 1