510(k) Report

FDA applicant

Sunstar Butler

Chicago, IL1 decision2005–20050 recalls

FDA records 1 decision for Sunstar Butler (Chicago, IL) in 2005: 1 510(k) clearance. All are in product code LBH (Varnish, Cavity). Its devices cite 2 predicates, 0 of them its own earlier devices. No 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 Sunstar Butler’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sunstar Butler since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sunstar Butler 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?

  • LBHVarnish, Cavity1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K050486Protect Tooth DesensitizerSunstar Butler · 20053cite it

What has FDA decided for it lately?

  • K050486Protect Tooth DesensitizerSunstar Butler · 2005

The one decision as Sunstar Butler →

Other applicant names beginning “Sunstar”

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

Sunstar Americas, Inc. 3Sunstar Suisse S.A. 1