510(k) Report

FDA applicant

Gc Orthodontics America, Inc.

Alsip, IL2 decisions2015–20150 recalls

FDA records 2 decisions for Gc Orthodontics America, Inc. (Alsip, IL) in 2015: 2 510(k) clearances. All are in product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin). 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 Gc Orthodontics America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2015: 2
2015high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Gc Orthodontics America, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DYHAdhesive, Bracket And Tooth Conditioner, Resin2decisions

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.

  • K150128GC Ortho Connect, GC Ortho Etching GelGc Orthodontics America, Inc. · 20151cites it

What has FDA decided for it lately?

  • K150128GC Ortho Connect, GC Ortho Etching GelGc Orthodontics America, Inc. · 2015
  • K143667GC KommonBaseGc Orthodontics America, Inc. · 2015

All 2 as Gc Orthodontics America, Inc. →