510(k) Report

FDA applicant

Vivadent (Usa), Inc.

Mchenry, IL17 decisions1978–19861 recall

FDA records 17 decisions for Vivadent (Usa), Inc. (Mchenry, IL) from 1978 to 1986: 17 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EMA (Cement, Dental). 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 Vivadent (Usa), Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vivadent (Usa), Inc. since 2007.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Vivadent (Usa), Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EBFMaterial, Tooth Shade, Resin4decisions
  • EMACement, Dental3decisions
  • EBCSealant, Pit And Fissure, And Conditioner2decisions
  • EBDCoating, Filling Material, Resin1decision
  • DYHAdhesive, Bracket And Tooth Conditioner, Resin1decision
  • EJKLiner, Cavity, Calcium Hydroxide1decision

Also: EAY (1), EBG (1), EJJ (1), EBL (1), KLE (1).

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K790439Contact ResinVivadent (Usa), Inc. · 19792cite it

What has FDA decided for it lately?

  • K863831Vivadent FilpinVivadent (Usa), Inc. · 1986
  • K823409Heliosit-OrthodonticVivadent (Usa), Inc. · 1983
  • K813015HeliosealVivadent (Usa), Inc. · 19811 recall
  • K802679SilanitVivadent (Usa), Inc. · 1980
  • K802684HeliomatVivadent (Usa), Inc. · 1980
  • K802683HeliositVivadent (Usa), Inc. · 1980
  • K802682Contact SealVivadent (Usa), Inc. · 1980
  • K802681HeliobondVivadent (Usa), Inc. · 1980

All 17 as Vivadent (Usa), Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K813015Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal…Feb 12, 2016Class II