510(k) Report

FDA applicant

Sunstar Americas, Inc.

Lake Bluff, IL3 decisions2011–20181 recall

FDA records 3 decisions for Sunstar Americas, Inc. (Lake Bluff, IL) from 2011 to 2018: 3 510(k) clearances. Most are in product codes EJR (Agent, Polishing, Abrasive, Oral Cavity) and NPK (Barrier, Synthetic, Intraoral). Its devices cite 10 predicates, 0 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 Sunstar Americas, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2011: 12013: 12018: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2021

2021: 1
2011high 1 (2021) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Sunstar Americas, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sunstar Americas, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • EJRAgent, Polishing, Abrasive, Oral Cavity1decision
  • NPKBarrier, Synthetic, Intraoral1decision
  • LFDSaliva, Artificial1decision

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K181134G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral SpraySunstar Americas, Inc. · 20181cites it

What has FDA decided for it lately?

  • K181134G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral SpraySunstar Americas, Inc. · 20181 recall
  • K132325Guidor Bioresorbable Matrix BarrierSunstar Americas, Inc. · 2013
  • K102053Butler Calci-Flor Prophylaxis PasteSunstar Americas, Inc. · 2011

All 3 as Sunstar Americas, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K181134SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0…Feb 18, 2021Class II

Other applicant names beginning “Sunstar”

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

Sunstar Suisse S.A. 1Sunstar Butler 1