510(k) Report

FDA applicant

Allesee Orthodontic Appliances

Orange, CA2 decisions2004–20100 recalls

FDA records 2 decisions for Allesee Orthodontic Appliances (Orange, CA) from 2004 to 2010: 2 510(k) clearances. All are in product code NXC (Aligner, Sequential). 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 Allesee Orthodontic Appliances’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Allesee Orthodontic Appliances 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?

  • NXCAligner, Sequential2decisions

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.

  • K040874Red, White & BlueAllesee Orthodontic Appliances · 20042cite it
  • K093821FS AlignerAllesee Orthodontic Appliances · 20101cites it

What has FDA decided for it lately?

  • K093821FS AlignerAllesee Orthodontic Appliances · 2010
  • K040874Red, White & BlueAllesee Orthodontic Appliances · 2004

All 2 as Allesee Orthodontic Appliances →